MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC FT CATHETER WITH SHERLOCK TPS STYLET 5F; 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	11/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by healthcare professional "we received supplies on friday, and our vas nurses were unpacking (was completely sealed) found food fragments." it was reported this occurred with three kits.This report addresses the first kit.
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refv0013 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (refv0013) have been reported from the same facility.
Event or Problem Description
It was reported by healthcare professional "we received supplies on friday, and our vas nurses were unpacking (was completely sealed) found food fragments." it was reported this occurred with three kits.This report addresses the first 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 lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of food particles within a shipping box is confirmed; however, the exact cause is unknown.One open box containing three sealed 5 fr dual lumen powerpicc ft 3cg kits was returned for evaluation.An initial visual observation showed grease stains on the cardboard of the opened box as well as on the surface of the sealed kits.Within the box, a relatively large amount of what appear to be crackers were found in and around the three sealed kits.Most of the food particles were found at the bottom of the box, and the tyvek of the kit at the bottom of the box was observed to be thoroughly saturated with a yellowish grease.Multiple layers of tape were observed on the top flaps of the cardboard box.Due to the opened state of the returned box, as well as the evidence that the box was sealed and re-sealed multiple times, it was not possible to determine when the food particles were introduced into the box.

• Brand Name: POWERPICC FT CATHETER WITH SHERLOCK TPS STYLET 5F
• 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12896474
• Report Number: 3006260740-2021-05050
• Device Sequence Number: 11962778
• Product Code: LJS
• UDI-Device Identifier: 00801741034572
• UDI-Public: (01)00801741034572
• 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: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2022

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: 1275108FD
• Device Lot Number: REFV0013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown