MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 3FR SL PROVENA MIDLINE MAX BARRIER KIT W/BIOPATCH AND PROBE COVER; MIDLINE CATHETER

Model Number N/A

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976)

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

Event Date 10/01/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported "i opened a midline kit today and found the tip of the introducer completely broken off from the inner dilator.The peel away sheath was intact when i found it, i peeled it away just to check the inner dilator once i found it like that." it was stated patient information is not relevant as this was discovered upon opening the kit, prior to the start of the procedure.

Event Description

It was reported "i opened a midline kit today and found the tip of the introducer completely broken off from the inner dilator.The peel away sheath was intact when i found it, i peeled it away just to check the inner dilator once i found it like that." it was stated patient information is not relevant as this was discovered upon opening the kit, prior to the start of the procedure.

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), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a detached hub is confirmed and was determined to be manufacturing related.One 3.5 fr x 5 cm microintroducer assembly was returned for evaluation.An initial visual observation showed the hub of the dilator was completely detached.A microscopic observation revealed a rim of material around the edge of the break on the proximal end of the shaft of the dilator with some locations exhibiting plastic deformation in the material.The proximal end of the shaft was observed to be smooth, flat, and flared, and striations were observed on this surface, suggesting this is the manufactured end.A circular indentation was observed on the distal end of the hub with rough edges that appear to align with the edges of the proximal end of the shaft.This circular indentation was observed to be somewhat shallow and suggests the dilator shaft was not positioned correctly during the molding process, which allowed the shaft to detach from the hub.The investigation was forwarded to the manufacturing facility for further evaluation, and bd is working closely with the manufacturing facility to prevent recurrence of the reported event.

• Brand Name: 3FR SL PROVENA MIDLINE MAX BARRIER KIT W/BIOPATCH AND PROBE COVER
• Type of Device: MIDLINE 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: 12686960
• MDR Text Key: 278100892
• Report Number: 3006260740-2021-04517
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741154003
• UDI-Public: (01)00801741154003
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153393
• 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: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2021
• 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: S4153108BDP
• Device Lot Number: REFR2776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2021
• 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