MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA CATHETER WITH SHERLOCK 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reez3496 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reez3496) have been reported from the same facility.
Event or Problem Description
It was reported "i opened up a replacement introducer & it slid perfectly in, but didn¿t fully peel apart leaving a plastic ring again around the catheter.Couldn't break it so ended up having to cut it loose with the scalpel (high risk for catheter puncture but he checked function multiple times after placement & didn't find any leakage).".
Event or Problem Description
It was reported "i opened up a replacement introducer & it slid perfectly in, but didn¿t fully peel apart leaving a plastic ring again around the catheter.Couldn¿t break it so ended up having to cut it loose with the scalpel (high risk for catheter puncture but he checked function multiple times after placement & didn¿t find any leakage).".
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, complaint and batch history, labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of difficulty splitting the sheath was confirmed and appears to be manufacturing related.A photograph of split introducer sheath interfacing with a powerpicc catheter was returned for evaluation.The introducer had been split longitudinally and only half of the device was visible in the photo.The handles of the sheath did not break away along the intended score line, releasing the catheter.Instead, the handles broke in an irregular fashion leaving the catheter shaft encased within a hard ring of plastic material from the sheath handle.The poor breakability of the handles were considered manufacturing related.Bd is working closely with manufacturing to prevent recurrence of the reported event.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERPICC PROVENA CATHETER WITH SHERLOCK 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
• MDR Report Key: 11974758
• Report Number: 3006260740-2021-02261
• Device Sequence Number: 14513935
• Product Code: LJS
• UDI-Device Identifier: 00801741141935
• UDI-Public: (01)00801741141935
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2021

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 Model Number: N/A
• Device Catalogue Number: CK000988
• Device Lot Number: REEZ3496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Initial Date Received by Manufacturer: 05/22/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 08/16/2021
• 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: Other