MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER 5F MAXIMAL BARRIER TRAY (DUAL-LUMEN) (55CM) (WITH MICROINTROD; 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)
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 redy1664 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the orange tab on the introducer sheath broke off.
Event or Problem Description
It was reported that the orange tab on the introducer sheath broke off.
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 sheath detaching from peel tabs is confirmed but the exact cause could not be determined.Three 5 fr dl powerpicc catheter kits were returned for investigation.The kits were returned fully sealed.Each kit label showed lot: redy1664.The kits were opened in order to inspect the microez microintroducer component.The microintroducers were removed from the kits.The tabs were observed to be intact with no apparent material damage.The samples appeared to be lot samples and did not match the sample which experienced the alleged event.Even pressure was applied to the tabs in order to peel the handles and sheath.Each set of tabs exhibited a clean break and grey sheath split.The tabs remained attached to their respective sheath portions.The lot samples did not exhibit the similar issues as the reported event.One photo sample of a peel-apart microez microintroducer sheath was also provided for evaluation.A product label sticker was present with lot: redy1664.The grey sheath was observed to be fully peeled.The orange peel tabs were separated from the peeled sheath.The points of contact between the sheath and the handles is not visible from the photo provided.Based on the description of the reported event, possible contributing factors include material damage and peel technique.Since the sheath was observed to be detached from the tabs in the photo sample, the complaint is confirmed; however, the exact cause could not be determined.A lot history review (lhr) of redy1664 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERPICC CATHETER 5F MAXIMAL BARRIER TRAY (DUAL-LUMEN) (55CM) (WITH MICROINTROD
• 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: 10189175
• Report Number: 3006260740-2020-02196
• Device Sequence Number: 10971520
• Product Code: LJS
• UDI-Device Identifier: 00801741028717
• UDI-Public: (01)00801741028717
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K051672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2020

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 Model Number: N/A
• Device Catalogue Number: CK000057
• Device Lot Number: REDY1664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 07/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1