MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT 3FR SL PROV ML; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	SP4153108DB
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 3.5 fr x 7 cm microintroducer was returned for evaluation.An initial visual observation showed use residue on the returned sample.The dilator was returned loose within the introducer sheath and was observed to be bent approximately 0.2 cm and 1.9 cm distal to the locking collar.A bend was also observed in the introducer sheath just distal to the t-handle.The bend in the introducer sheath appears to align with the bend 1.9 cm distal to the locking collar in the dilator; however, the dilator in this position was found to protrude slightly from the introducer sheath and not locked onto the t-handle of the introducer sheath.A microscopic observation revealed the distal tip of the introducer sheath was damaged and plastically deformed in multiple locations around its circumference, and the edges of the sheath tip were observed to flare outward.No damage was observed on the distal tip of the dilator.While the root cause of the damage observed on the introducer sheath is unknown, possible causes include damage during handling or use.As a note, the product ifu states: ¿do not withdraw dilator from microintroducer sheath until sheath is within vessel to minimize the risk of damage to sheath tip.¿ a lot history review (lhr) of reeq0652 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.
Event or Problem Description
It was reported a defect was found with an introducer, not allowing it to thread in easily.Additional information received via medwatch "vat nurse placing a midline, unable to thread in introducer, even after nicking the patient, introducer removed and that is when the defect was noticed, a new midline kit opened to retrieve second introducer, no issues after using new introducer.It was reported this occurred twice.This report addresses the first event.

• Brand Name: DOT 3FR SL PROV ML
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11060901
• Report Number: 3006260740-2020-21036
• Device Sequence Number: 3206793
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2020

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: 04/30/2021
• Device Model Number: SP4153108DB
• Device Catalogue Number: SP4153108DB
• Device Lot Number: REEQ0652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 12/22/2020
• 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