MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC PROVENA CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	CK000284A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/26/2018
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 recs0288 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that when the picc kit was pulled out of the box it has a wooden splinter stuck in kit.
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 damaged packaging is confirmed but the exact cause could not be determined from the photos provided.Three photo samples of a powerpicc kit were returned for investigation.The first photo shows what appears to be a wooden splinter piercing the clear outer packaging.The second photo shows an overall picture of the kit and the wooden splinter.The third photo shows the sample kit and wooden splinter from another angle.Based on the photo samples provided, possible contributing factors include damage during storage and handling.Since the location at which the wooden splinter was introduced could not be determined, the complaint is confirmed, cause unknown.A lot history review (lhr) of recs0288 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that when the picc kit was pulled out of the box it has a wooden splinter stuck in kit.

• Brand Name: POWERPICC PROVENA CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET
• 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: 8118461
• Report Number: 3006260740-2018-03428
• Device Sequence Number: 1710660
• Product Code: LJS
• UDI-Device Identifier: 00801741141942
• UDI-Public: (01)00801741141942
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• 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): 01/16/2019

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: CK000284A
• Device Catalogue Number: CK000284A
• Device Lot Number: RECS0288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1