MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PROV 4F DL MAX 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	S1274108D
Medical Device Problem Codes	Material Deformation (2976); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
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 2694204 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the introducer sheared when attempting to access the skin.A new introducer was used with no issues.No other information was 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, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged microintroducer is confirmed; however, the exact cause is unknown.One 4.5 fr x 7 cm microintroducer was returned for evaluation.An initial visual observation showed use residue on the returned sample.The distal end of the sheath was observed to be split and damaged.Evidence of buckling was observed in the sheath approximately 2.5 cm proximal to its tip.The distal end of the dilator was observed to be slightly bent.A microscopic observation revealed a large split in the distal tip of the introducer sheath which was observed to also be plastically deformed in multiple locations around its circumference.The edge opposite the large split was observed to be folded inward and over itself and buckled at the base of the fold.While the root cause of the damage observed on the introducer sheath is unknown, possible causes include damage during handling or use.
Event or Problem Description
It was reported that the introducer sheared when attempting to access the skin.A new introducer was used with no issues.Additional info: was there any patient harm reported? yes may have led to increase bleeding at the site.

• Brand Name: DOT PROV 4F DL MAX 3CG
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11720412
• Report Number: 3006260740-2021-01531
• Device Sequence Number: 4220423
• Product Code: LJS
• UDI-Device Identifier: 00801741130366
• UDI-Public: (01)00801741130366
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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: S1274108D
• Device Catalogue Number: S1274108D
• Device Lot Number: REEW0876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 07/01/2021
• 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
• Patient Age: 7 DA
• Patient Weight: 3