MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 UNIVERSAL MICROINTRODUCER KIT PTFE PA SHEATH INTRO 4.5F X 5CM; INTRODUCER, CATHETER

Model Number N/A

Device Problems Material Deformation (2976); Difficult or Delayed Separation (4044)

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

Event Date 04/24/2022

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refv2473 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the introducer sheath bifurcated at the proximal end.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: previous complaints, patient severity, applicable manufacturing records, submitted photograph, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged introducer sheath was confirmed, but the exact cause was unknown.A photograph was provided which depicted a ptfe introducer sheath.The sheath had not been split and the distal edge of the sheath was damaged along what appeared to be the entire edge.No observable evidence suggested the cause of this event.A review of the manufacture records associated with the provided lot number found no potential cause identified during product manufacture.Should the physical sample be returned at a later time, this investigation will be updated.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported that the introducer sheath bifurcated at the proximal end.No other information was provided.

• Brand Name: UNIVERSAL MICROINTRODUCER KIT PTFE PA SHEATH INTRO 4.5F X 5CM
• Type of Device: INTRODUCER, CATHETER
• 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: 14465284
• MDR Text Key: 292358422
• Report Number: 3006260740-2022-01882
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K915167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2022
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2021
• 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