MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 4F; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reen3317 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the device was not used on a patient, prior to use the hub area had a white substance that looked like corrosion.

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, 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 foreign material in the device was unconfirmed because the problem could not be reproduced.The product returned for evaluation was one 21ga safety introducer needle.The sample appeared free of obvious usage residues and the safety mechanism was not engaged.A region of what appeared to be material discoloration was observed at the interface between the luer material and the needle shaft.Microscopic inspection of the sample confirmed a region of material discoloration at the luer/needle interface.Following bisection of the sample within the discolored region, inspection of the material did not reveal any obvious deformation.The reported ¿white substance¿ appeared to be referring to the observed region of material discoloration.Such discoloration may be the result of internal stresses experienced by the luer polymer material during or following device manufacture, but did not appear cause any device defect or disfunction.Consequently this complaint is unconfirmed at this time.A lot history review (lhr) of reen3317 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the device was not used on a patient, prior to use the hub area had a white substance that looked like corrosion.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 4F
• Type of Device: 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: 10518759
• MDR Text Key: 206521324
• Report Number: 3006260740-2020-03224
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741138973
• UDI-Public: (01)00801741138973
• Combination Product (y/n): N
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/30/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 2194108
• Device Lot Number: REEN3317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 09/16/2020
• Supplement Dates FDA Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1