MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PPICC 4F SL 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of regq1431 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the customer via medwatch the "picc line inserted unable to pass, began to pull catheter out to end procedure and begin to meet resistance at 37 cm.Massaged muscle and injected rest of lidocaine to area.Continued to massage area and line was then able to become dislodged and a pop sound.At the end of the tip was a small knot.".
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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a knotted catheter was confirmed.The product returned for evaluation was one 4fr s/l powerpicc catheter.Light usage residues were observed throughout the sample.The catheter was knotted near the distal end of the catheter.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be fully occluded due to the knot.Microscopic inspection of the catheter confirmed the shaft to be tightly knotted near the distal end.The catheter tip was confirmed to be knotted near the distal end.Both the presence of biological residue and the event description suggested that knot was formed during device insertion.Such damage can occur if insertion is attempted against resistance, particularly without the support of the stylet.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported by the customer via medwatch the "picc line inserted unable to pass, began to pull catheter out to end procedure and begin to meet resistance at 37 cm.Massaged muscle and injected rest of lidocaine to area.Continued to massage area and line was then able to become dislodged and a pop sound.At the end of the tip was a small knot.".

• Brand Name: PPICC 4F SL 3CG
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15564369
• Report Number: 3006260740-2022-03934
• Device Sequence Number: 2984642
• Product Code: LJS
• UDI-Device Identifier: 00801741216008
• UDI-Public: (01)00801741216008
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: N/A
• Device Catalogue Number: CK000986
• Device Lot Number: REGQ1431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2022
• Supplement Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 10/07/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 108 KG