MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER; INTRODUCER, CATHETER

Model Number N/A

Device Problems Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recv0408 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported during the picc catheterization process for the patient at 16:00 on (b)(6) 2020, after unpacking the peripherally intubated central venous catheter kit and accessories, it was found that there was a black foreign body in the size of a rice grain.Replace the cannula package immediately and report to the hospital equipment section.

Event Description

It was reported during the picc catheterization process for the patient at 16:00 on (b)(6) 2020, after unpacking the peripherally intubated central venous catheter kit and accessories, it was found that there was a black foreign body in the size of a rice grain.Replace the cannula package immediately and report to the hospital equipment section.

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, applicable manufacturing records, sample analysis, photo analysis, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of foreign material in the device packaging was inconclusive due to the sample condition.The product returned for evaluation was a microez microintroducer kit and two photos.The kit had been opened prior to being received and had been taped back shut.All kit components were returned within the packaging; a guidewire, an iv catheter, an introducer needle, and a scalpel.The foreign material seen in the photos was no longer present.However, on the right side of the packaging a small speck of brown material was found, and small white crystalline materials were also seen in the package.The photos that were returned had a much larger foreign material than was seen on examination of the returned product.It is likely that the foreign material was displaced before the sample was evaluated (e.G.At complainant facility, in shipping, in-processing etc.) the foreign material seen in the photos was a small black speck that was present on the packaging sheath of the introducer needle.However, the identity of the foreign material could not be determined.Based on evaluation of the returned photos and kit, possible contributing factors include contamination during the manufacturing process or after the kit had been opened.Because the kit had been opened, it cannot be concluded when the material entered the kit.

• Brand Name: UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRODUCER
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10685613
• MDR Text Key: 213438301
• Report Number: 3006260740-2020-20131
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K915167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• 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: RECV0408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other