MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD® POLY MIDLINE CATHETER, 4F SL

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	10/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a faulty dilator.Add info rcvd: placed line with faulty dilator.Used dilator from a separate kit to complete line placement.Was there patient harm reported?: no.(b)(6) 2021: the returned sample exhibited a deformed sheath.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged dilator was confirmed; however, the root cause was not identified.The product returned for evaluation was one photograph which depicted a microintroducer dilator/sheath.The depicted portion of the device included the distal tip and part of the shaft.The dilator was inlaid through the sheath.Biological residue was observed on the sample.The tip of the peel-apart sheath appeared deformed and compressed.The bunched region appeared flared away from the dilator shaft.The sheath deformation and biological residue were consistent with damage caused by attempted advancement against resistance, such as into tissue; however, inspection of the photograph was insufficient to identify if difficult insertion resulted in device damage, or if pre-existing device damage resulted in difficult insertion.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.A lot history review (lhr) of reft3561 showed no other similar product complaint(s) from this lot number.

• Brand Name: BARD® POLY MIDLINE CATHETER, 4F SL
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13018400
• Report Number: 3006260740-2021-05325
• Device Sequence Number: 12006044
• Product Code: PND
• UDI-Device Identifier: 00801741182693
• UDI-Public: (01)00801741182693
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K001901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/30/2021

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 Model Number: N/A
• Device Catalogue Number: CK000107A
• Device Lot Number: REFT3561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2021
• 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: 64 YR
• Patient Sex: Male