MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 18G X 10 CM WITH BIOPATCH AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Activation Problem (4042)

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

Event Date 12/05/2022

Event Type  malfunction  

Event Description

It was reported by the customer "i was doing an epiv today and the needle safety did not deploy.It looks like it got stuck in the chamber.I did check the guidewire before i used it and there was no hesitation or issue when testing or when i advanced it." no other information was provided.

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of regw0769 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by the customer "i was doing an epiv today and the needle safety did not deploy.It looks like it got stuck in the chamber.I did check the guidewire before i used it and there was no hesitation or issue when testing or when i advanced it." no other information was provided.

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, applicable previous investigation(s), sample analysis, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of safety failure was confirmed and the cause appeared to be manufacturing-related.The product returned for evaluation was one 18ga x 18cm powerglide pro midline catheter assembly.The catheter had been advanced and was not returned for evaluation.Although the safety mechanism carrier appeared to had been advanced with the catheter, the safety mechanism remained near the proximal end of the needle shaft.Initial attempts to advance the safety mechanism were unsuccessful.The safety cannister was not mobile on the needle shaft.Microscopic inspection of the needle shaft revealed clear material that appeared consistent with adhesive on the needle shaft, appearing to bond the safety mechanism to the needle.Mobility was established following breaking of the bond between the safety mechanism and the needle shaft.The safety was then successfully engaged over the needle tip.The adhesive-like material on the needle shaft appeared to prevent initial activation of the safety mechanism during the catheter placement procedure.The material appeared to have been deposited during device manufacture.Photographs have been forwarded to the manufacturing site for further evaluation.

• Brand Name: FULL KIT 18G X 10 CM WITH BIOPATCH AND PROBE COVER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16042723
• MDR Text Key: 306418914
• Report Number: 3006260740-2022-05845
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: F318108PT
• Device Lot Number: REGW0769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• 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