MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER, 5F DL, FT, 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redr0532 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The following was reported by a rn, "my pt came into ed last evening around 530 with complaint of broken picc.I came to ed and found picc was broken in 2 pieces at the point where the line connects to the suture wing.The pt stated he was driving and felt a pop, he looked and noticed what looked like a ¿fissure¿ in the part of the line that was out on the arm.There was about 2 cm out on the arm.Upon trying to examine the line to see what had happened, the line broke into 2 pieces.He immediately came to ed.Upon pulling the line out further, it was noted that there were 2-3 other cracks in the line, all with in the first 6 cm.The rest of the line was intact.The line was placed 10/31 by myself with no difficulty.The dressing was changed 11/1 prior to pt discharge and that dressing was still in place.He was getting vanc and fluids through the line and home health was flushing with heparin per pt.A new picc line was placed without difficulty in the same arm.".
Event or Problem Description
The following was reported by a rn, "my pt came into ed last evening around 530 with complaint of broken picc.I came to ed and found picc was broken in 2 pieces at the point where the line connects to the suture wing.The pt stated he was driving and felt a pop, he looked and noticed what looked like a ¿fissure¿ in the part of the line that was out on the arm.There was about 2 cm out on the arm.Upon trying to examine the line to see what had happened, the line broke into 2 pieces.He immediately came to ed.Upon pulling the line out further, it was noted that there were 2-3 other cracks in the line, all with in the first 6 cm.The rest of the line was intact.The line was placed 10/31 by myself with no difficulty.The dressing was changed 11/1 prior to pt discharge and that dressing was still in place.He was getting vanc and fluids through the line and home health was flushing with heparin per pt.A new picc line was placed without difficulty in the same arm.".
Additional Manufacturer Narrative
H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a broken picc was confirmed, but the exact mechanism of damage could not be determined.One 5fr dual-lumen powerpicc solo ft was returned for investigation.Evidence of use was observed on the returned sample.The catheter was received in two segments.The dual-lumen tubing broke at the distal end of the molded bifurcation.A 1.3cm longitudinal split extended from the broken end of the catheter.Circumferential splits were observed 3.5cm, 5.4cm, and 6.5cm from the broken end of the catheter.Longitudinal splits were observed at each circumferential split.A functional test confirmed that the lumens were patent to infusion; however fluid leaked from the circumferential and longitudinal breaches in the catheter tubing.The depth markers near the breaches were partially worn from the catheter.The wall thickness of the catheter was within specification.Potential contributing factors of the break and breaches in the catheter include material fatigue and tensile stress; however, the exact mechanism of damage was undetermined.A lot history review (lhr) of redr0532 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The following was reported by a rn, "my pt came into ed last evening around 530 with complaint of broken picc.I came to ed and found picc was broken in 2 pieces at the point where the line connects to the suture wing.The pt stated he was driving and felt a pop, he looked and noticed what looked like a ¿fissure¿ in the part of the line that was out on the arm.There was about 2 cm out on the arm.Upon trying to examine the line to see what had happened, the line broke into 2 pieces.He immediately came to ed.Upon pulling the line out further, it was noted that there were 2-3 other cracks in the line, all with in the first 6 cm.The rest of the line was intact.The line was placed 10/31 by myself with no difficulty.The dressing was changed 11/1 prior to pt discharge and that dressing was still in place.He was getting vanc and fluids through the line and home health was flushing with heparin per pt.A new picc line was placed without difficulty in the same arm." (b)(6)20- medwatch received stated, "pt stated he was driving and felt a pop sensation.He looked down and it appeared like there was a "fissure" in his picc line.Upon trying to examine the life closer, the line broke into 2 pieces and the pt immediately came to ed.Upon removal of line, several other cracks were noted in the line wall within the first 6 cm.The rest of the line was intact and 42 cm were removed.Pt had to have new picc line placed.No suspected misuse of picc by pt.".
Additional Manufacturer Narrative
H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a broken picc was confirmed, but the exact mechanism of damage could not be determined.One 5fr dual-lumen powerpicc solo ft was returned for investigation.Evidence of use was observed on the returned sample.The catheter was received in two segments.The dual-lumen tubing broke at the distal end of the molded bifurcation.A 1.3cm longitudinal split extended from the broken end of the catheter.Circumferential splits were observed 3.5cm, 5.4cm, and 6.5cm from the broken end of the catheter.Longitudinal splits were observed at each circumferential split.A functional test confirmed that the lumens were patent to infusion; however fluid leaked from the circumferential and longitudinal breaches in the catheter tubing.The depth markers near the breaches were partially worn from the catheter.The wall thickness of the catheter was within specification.Potential contributing factors of the break and breaches in the catheter include material fatigue and tensile stress; however, the exact mechanism of damage was undetermined.A lot history review (lhr) of redr0532 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERPICC SOLO CATHETER, 5F DL, FT, 3CG
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9372363
• Report Number: 3006260740-2019-03694
• Device Sequence Number: 3043233
• Product Code: LJS
• UDI-Device Identifier: 00801741161155
• UDI-Public: (01)00801741161155
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2020
• Report Date (Section F): 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: N/A
• Device Catalogue Number: CK000290C
• Device Lot Number: REDR0532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/07/2019
• Event Location: Home
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 01/09/2020; 02/19/2020
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 01/28/2020; 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 11/18/2019