MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 5 F POLYURETHANE CATHETER NURSING BASIC TRAY WITH MICROINTRODUCER (55C; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of redt0801 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that when pulling the guide to cut the catheter, white dirt with flaking appearance was identified.The catheter was introduced into the patient without complications, but we were concerned if these dirt remained inside the catheter.The problem was evidenced during the passage of the power picc catheter.
Event or Problem Description
It was reported that when pulling the guide to cut the catheter, white dirt with flaking appearance was identified.The catheter was introduced into the patient without complications, but we were concerned if these dirt remained inside the catheter.The problem was evidenced during the passage of the power picc catheter.
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 lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of foreign matter is inconclusive due to poor sample condition.Four photo samples of a stylet were provided for evaluation.The stylet is shown outside of patient use and is stored within a plastic bag.The red ¿warning¿ tag is visible near the black tab attached to the stylet.The photos show different angles of the stylet within the plastic bag; however, additional details and information could not be clearly discerned as the wire surface was not clearly visible.The presence of residue could not be determined due to the quality of the photo and lack of a physical sample.A review of the manufacturing records did not reveal any evidence to suggest a manufacturing related root cause contributed to the reported issue.Based on the description of the reported event, possible contributing factors include precipitant formation during flushing and material deposition prior to packaging.Since the complaint could not be confirmed from the images provided, the complaint remains inconclusive at this time.A lot history review (lhr) of redt0801 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERPICC 5 F POLYURETHANE CATHETER NURSING BASIC TRAY WITH MICROINTRODUCER (55C
• 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: 10620571
• Report Number: 3006260740-2020-03432
• Device Sequence Number: 3232569
• Product Code: LJS
• UDI-Device Identifier: 00801741027666
• UDI-Public: (01)00801741027666
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K033389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020

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: 05/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 3175118
• Device Lot Number: REDT0801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/09/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1