MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT 3FR SL PROV ML; MIDLINE CATHETER

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of regp1017 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the customer "that the introducer sheath began to split or frey at the skin which significantly restricted access beyond the skin.Customer had to open a new set in order to place the line appropriately using a new introducer".
Event or Problem Description
It was reported by the customer "that the introducer sheath began to split or frey at the skin which significantly restricted access beyond the skin.Customer had to open new set in order to place line appropriately using a new introducer.".
Additional 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 and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged sheath tip is confirmed and appears to be manufacturing related.One 3.5 fr x 7 cm microez microintroducer was returned for evaluation.The dilator was not returned.The product sticker label indicates lot: regp1017.The proximal end of the sheath was observed to be kinked causing the sheath tubing to be compressed.The length of the sheath contained a slight curvature.The distal tip of the sheath contained deformation which appeared to be inward bunching of the material.Microscopic inspection of the sheath tip revealed a blunt tip surface.The tip taper did not appear to be fully formed.The blunt sheath tip likely contributed to the resistance experience during insertion; therefore, the complaint is confirmed to be manufacturing related.Bd is working closely with the manufacturing facility to prevent reoccurrence of the reported event.

• Brand Name: DOT 3FR SL PROV ML
• Common Device Name: 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15584386
• Report Number: 3006260740-2022-03958
• Device Sequence Number: 7141924
• Product Code: PND
• UDI-Device Identifier: 00801741185076
• UDI-Public: (01)00801741185076
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: SP4153108DB
• Device Lot Number: REGP1017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2022
• Supplement Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 63 KG