MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SHERLOCK 3CG BARD MYPICC KIT (5F) (DUAL-LUMEN) (TPS); CATHETER,INTRAVASCULAR,THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Death (1802)
Date of Event	10/11/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of 18kbn218 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that a picc was inserted on 10/4 and worked well.On (b)(6) 2019, the patient expired.When the picc was removed, a hole was noticed in the middle of the picc.No other information was provided.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged catheter was confirmed, and the cause appears to be use related.The product returned for evaluation was one 5 fr dual lumen powerpicc.An initial visual observation showed use residue on the returned sample.A large longitudinal split was observed in the catheter at the 25 cm depth marker.A microscopic observation revealed the edges of the spilt were wavy but smooth, and the fracture surfaces were observed to be flat and granular, which is characteristic of tearing failure modes.The damage observed in the returned sample is characteristic of over-pressurization (burst) damage.This can occur through the use of syringes smaller than 10ml, by flushing against an occlusion, or due to excessive force applied during infusion procedures.A lot history review (lhr) of 18kbn218 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that a picc was inserted on 10/4 and worked well.On (b)(6) 2019, the patient expired.When the picc was removed, a hole was noticed in the middle of the picc.No other information was provided.

• Brand Name: POWERPICC SHERLOCK 3CG BARD MYPICC KIT (5F) (DUAL-LUMEN) (TPS)
• 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: 9269139
• Report Number: 3006260740-2019-03444
• Device Sequence Number: 1951408
• Product Code: LJS
• UDI-Device Identifier: 00801741042973
• UDI-Public: (01)00801741042973
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CK000171
• Device Lot Number: 18KBN218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 11/22/2019
• 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: Death