MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SHERLOCK 3CG BARD MYPICC KIT (4F) (SINGLE LUMEN) (TPS); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	Tissue Damage (2104)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of 18ab5884 showed no other similar product complaint(s) from this lot number.(b)(4).
Event or Problem Description
It was reported via medwatch "powerpicc inserted (b)(4) 2019.Received multiple chemo infusions.Upon removal 4 months later, picc line broke.Retained picc removed in or with right basilic vein cut down under local anesthesia.".
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, and labeling.Based on a review of this information, the following was concluded: the complaint of a broken catheter was confirmed and the damage appeared to be associated with use.One 21.1 cm segment of single-lumen powerpicc tubing was returned for investigation.The 20 ¿ 41 cm marks were observed on the returned catheter segment.The catheter exhibited evidence of use.The distal end of the catheter segment exhibited a smooth, glossy, and striated surface, which is indicative of a sharp instrument cut.The proximal end of the catheter segment was rough, jagged, granular, and uneven, which is consistent with the reported break.Up to 7cm of surface cracking was observed at the proximal end of the tubing.A tactual investigation revealed whitening of the catheter material at the cracks when stretching the catheter.The observed damage is consistent with a break due to tensile stress.It was reported that the catheter broke during removal.Possible contributing factors of the resistance include material degradation, fibrin sheath formation, and venospasm.During the removal process, the catheter should be removed slowly.Excessive force should not be used.If resistance is felt, the removal process should be stopped.A warm compress should be applied and the removal procedure should resume after waiting 20-30 minutes.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of 18ab5884 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via medwatch "powerpicc inserted january 2019.Received multiple chemo infusions.Upon removal 4 months later, picc line broke.Retained picc removed in or with right basilic vein cut down under local anesthesia.".

• Brand Name: POWERPICC SHERLOCK 3CG BARD MYPICC KIT (4F) (SINGLE 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: 8850485
• Report Number: 3006260740-2019-02259
• Device Sequence Number: 16225502
• Product Code: LJS
• UDI-Device Identifier: 00801741042966
• UDI-Public: (01)00801741042966
• 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
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019
• Report Date (Section F): 07/10/2019

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 Model Number: N/A
• Device Catalogue Number: CK000170A
• Device Lot Number: 18AB5884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2019
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 09/11/2019
• 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: Required Intervention
• Patient Age: 42 YR