MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER 5F DUAL LUMEN 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
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 20dbe761 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "appears to have been an insect (part of) leg or wing in the sterile custom picc kit.".
Event or Problem Description
It was reported "appears to have been an insect (part of) leg or wing in the sterile custom picc kit.".
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, applicable previous investigation(s), labeling, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded.The complaint of foreign matter within the packaging was inconclusive due to the sample condition.The product returned for evaluation was an opened picc kit.The kit was received wrapped in two csr wraps.Once the wraps were opened, the kit was observed to have multiple kit components present, but they were found outside of their original packaging pattern as they were not in their packaging slots.The components appeared unused and free from residual material, except for the lidocaine vial.The lidocaine vial was received empty, it had been broken along the score lines on the vial.The catheter was found within the packaging tube and the packaging tube was found within the intended packaging retention slot.A tan foreign object was observed in the packaging tray, in the depressed component cavity along the catheter retention slot.The foreign body was measured to be 0.30¿ wide and 0.09¿ high.The foreign body was examined microscopically.The material appeared to be organic in nature.The coloration included brown, tan, and clear iridescent sections.The foreign matter appeared to be from an insect origin but could not be identified with certainty.Possible contributing factors include contamination during the manufacturing/packaging process or after the kit had been opened.Because the kit had been opened, it cannot be concluded when the foreign object entered the tray.The end-item packaging facility has been notified of this complaint.H3 other text: evaluation findings are in section h.11.

• Brand Name: POWERPICC CATHETER 5F DUAL LUMEN 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: 11422475
• Report Number: 3006260740-2021-00632
• Device Sequence Number: 4053441
• Product Code: LJS
• UDI-Device Identifier: 00801741189043
• UDI-Public: (01)00801741189043
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• 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): 04/21/2021

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: CK000592A
• Device Lot Number: 20DBE761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 05/21/2021
• 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