MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F X 5CM; INTRODUCER, CATHETER

Model Number N/A

Device Problem Corroded (1131)

Patient Problem No Patient Involvement (2645)

Event Date 10/07/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of rebv1133 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that corrosive rust was found with the blade after the unpacking for puncture.Device was not used on a patient.

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 rust on a scalpel is confirmed; however, the exact cause is unknown.One scalpel, one 4.5 fr microintroducer, one 21 g introducer needle, one 20 g iv introducer needle, and one 0.018 in.Guidewire in a plastic hoop were returned for evaluation.An initial visual observation showed a reddish-brown residue on the blade of the scalpel as well as on the guidewire and on both introducer needles.A microscopic observation revealed no damage on any of the returned components.While a reddish-brown residue was observed on the returned samples, it is unknown how this residue accumulated on the returned samples.Possible contributing factors include moisture contacting the kit components during transit, storage, or after removal from the packaging.The appropriate manufacturing records were reviewed, and no evidence of manufacturing-related deviations or issues related to this product failure were found.A lot history review (lhr) of rebv1133 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that corrosive rust was found with the blade after the unpacking for puncture.Device was not used on a patient.

• Brand Name: UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER 4.5F X 5CM
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9256920
• MDR Text Key: 164412585
• Report Number: 3006260740-2019-03391
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00801741074530
• UDI-Public: (01)00801741074530
• Combination Product (y/n): N
• PMA/PMN Number: K915167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• 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: 0668945
• Device Lot Number: REBV1133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Event Location: Hospital
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1