MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PPICC 4F SL 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of redt4612 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "on (b)(6) 2020 we had a faulty introducer in a 4fr sl picc kit (lot#redt4612).The introducer had a burr on the end and a striated circular line in the middle of the catheter.".
Event or Problem Description
It was reported "on (b)(6) 2020 we had a faulty introducer in a 4fr sl picc kit (lot # redt4612).The introducer had a burr on the end and a striated circular line in the middle of the catheter.".
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 introducer sheath tip is confirmed; however, the exact cause is unknown.One 4.5 fr 7 cm microintroducer was returned for evaluation.An initial visual observation showed use residue on the returned sample.The introducer sheath was observed to be buckled on the dilator approximately 5.1 cm distal to the t-handle.The distal tip of the introducer sheath was observed to be damaged.A microscopic observation revealed the edge of the distal tip of the introducer sheath was split and plastically deformed at multiple locations along its circumference.One edge of the distal tip was observed to be buckled and slightly folded under itself.While the root cause of the damage observed on the introducer sheath is unknown, possible causes include damage during handling or use.A lot history review (lhr) of redt4612 showed no other similar product complaint(s) from this lot number.

• Brand Name: DOT PPICC 4F SL 3CG
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9672118
• Report Number: 3006260740-2020-00392
• Device Sequence Number: 13548142
• Product Code: LJS
• UDI-Device Identifier: 00801741155741
• UDI-Public: (01)00801741155741
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2020

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: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: CK000854
• Device Lot Number: REDT4612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 DA
• Patient Weight: 75