MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 RADSTIC RADIOLOGY MI KIT PTFE PA SHEATH INTRO 5FX10CM; INTRODUCER, 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	05/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reew2820 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the front end is not straight and stuck.The component involved is the dilator tip.No other information provided.
Event or Problem Description
It was reported that the front end is not straight and stuck.The component involved is the dilator tip.No other information provided.
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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint that the introducer was not straight and stuck was inconclusive and could not be verified from the photograph that was provided for investigation.The photo showed a 5 fr microintroducer in open packaging.The sample exhibited evidence of use.What appeared to be blood residue was observed on the external surface of the white luer adaptor.The distal end of the vessel dilator exhibited discoloration, which may indicate that blood residue was present within the dilator.The distal end of the sheath and dilator were circled in the image.No damage could be observed in the photo at the distal end of the sheath or dilator; therefore, the complaint was inconclusive and the root cause of the complaint could not be determined.H3 other text : device evaluation findings are in the manufacturer's note.

• Brand Name: RADSTIC RADIOLOGY MI KIT PTFE PA SHEATH INTRO 5FX10CM
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12218024
• Report Number: 3006260740-2021-02941
• Device Sequence Number: 16491380
• Product Code: DYB
• UDI-Device Identifier: 00801741074585
• UDI-Public: (01)00801741074585
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K915167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2021

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: 0669050
• Device Lot Number: REEW2820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other