MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO 6 FR TL WITH SHERLOCK 3CG STYLET; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number	1396118
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rebn1396 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported on 08/09/2017 that when the white lumen was flushed it leaked saline.The left connector was replaced, but when flushed again, the same issue occurred.The connector was removed and the valve was reportedly broken.There was no reported patient injury.On 08/25/2017- per facility report, picc catheter leaking and disintegrated/cracked at the proximal valve.Line unusable.Picc removed.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a crack in the white connector was confirmed, and was considered manufacturing related.The implicated and returned product was a 6fr triple-lumen powerpicc solo.The white connector was cracked and portions of the connector were not returned for investigation.A cavity was observed in the white molded material.The valve was still held in place.The cavity identification was not present on the returned portion of the connector.No cracks were observed on the other connectors.The returned sample resembled the product in the returned photo.The complaint sample was forwarded to the manufacturing facility for further review.(b)(4) evaluation: the complaint for ¿valve cracked¿ is confirmed according the evaluation the sample received which showed valve part cracked of the lumen white; showed a bubble within valve, maybe these are caused by the incorrect molding process, leading to valve breakage.This condition cause leak in the device.Therefore the cause for this complaint is manufacturing related.A lot history review (lhr) of rebn1396 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported on 08/09/2017 that when the white lumen was flushed it leaked saline.The left connector was replaced, but when flushed again, the same issue occurred.The connector was removed and the valve was reportedly broken.There was no reported patient injury.08/25/2017- per facility report, picc catheter leaking and disintegrated/cracked at the proximal valve.Line unusable.Picc removed.

• Brand Name: POWERPICC SOLO 6 FR TL WITH SHERLOCK 3CG STYLET
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6836200
• Report Number: 3006260740-2017-01482
• Device Sequence Number: 659414
• Product Code: LJS
• UDI-Device Identifier: 00801741034770
• UDI-Public: (01)00801741034770
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2018

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: 1396118
• Device Catalogue Number: 1396118
• Device Lot Number: REBN1396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/10/2017
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1