MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 6 FR TL POWERPICC SOLO NURSE FULL WITH MI; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number	3396108
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2017
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebr0557 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that the line was never inserted due to pre-insertion discovery of the hub crack, a new kit was opened and used to complete the procedure.No injury to patient was reported.
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 cracked luer connector was confirmed and the cause appeared to be manufacturing related.The product returned for evaluation was a 6fr t/l powerpicc solo catheter.The white solo connector was broken and a segment was missing and not returned for evaluation.The connector fracture was primarily oriented in the longitudinal direction.The remaining luer threads appeared normally formed and undamaged.Microscopic examination of the fracture surfaces revealed a void within the wall of the connector.The fracture surfaces, outside the void, were rough and granular in nature.The unused state of the catheter, and apparent brittle nature of the break, suggest that this issue may be related to the manufacturing or molding process of the white cap.The sample was sent to the manufacturing facility for further review.Manufacturing evaluation: the complaint for ¿valve cracked¿ is confirmed according the evaluation the sample received which showed valve part cracked of the lumen white; a void was seen within the valve wall very similar to bubbles, 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.An internal event was opened for the tracking of this issue.A lot history review (lhr) of rebr0557 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that they had a defective picc.It was reported by the facility that the line was never inserted due to pre-insertion discovery of the hub crack, a new kit was opened and used to complete the procedure.

• Brand Name: 6 FR TL POWERPICC SOLO NURSE FULL WITH MI
• 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: 6765686
• Report Number: 3006260740-2017-01219
• Device Sequence Number: 2013282
• Product Code: LJS
• UDI-Device Identifier: 00801741028397
• UDI-Public: (01)00801741028397
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2017

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: 09/30/2018
• Device Model Number: 3396108
• Device Catalogue Number: 3396108
• Device Lot Number: REBR0557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/12/2017
• Supplement Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 08/03/2017
• Supplement Report FDA Received Date: 10/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1