MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SL CV FOR MAQUET IAB; STAND, INFUSION

Model Number N/A

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2021

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of foreign material within the kit is confirmed and appears to be manufacturing related.Three sealed statlock maquet iab packages were returned for evaluation.Two photos of the statlocks packages were also returned for evaluation.The photos contain three packages which correspond which the conditions of the returned samples.The product information indicated lot: jufq8517.Two kits were observed to contain a hard, plastic material.The material was observed to be a brittle plastic when touched.The third sealed kit was observed to contain a hair.Since the hair and plastic were found to be present within a sealed kit, the complaint is confirmed.Bd is working closely with the manufacturing facility to prevent recurrence of the reported event.A lot history review (lhr) of jufq8517 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (jufq8517) have been reported from the same facility.

Event Description

It was reported a package with foreign matter in the pouch.No other information was provided.Three device samples were returned.This report addresses the second device.

• Brand Name: SL CV FOR MAQUET IAB
• Type of Device: STAND, INFUSION
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• Manufacturer Contact: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12594942
• MDR Text Key: 275380795
• Report Number: 3006260740-2021-04291
• Device Sequence Number: 1
• Product Code: FOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0684000472
• Device Lot Number: JUFQ8517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other