MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA SOLO 5F DL FT MAX BARRIER PLUS KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2022
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 refx2578 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "picc nurse reported the following."placed a dl picc and the peel-away sheath broke apart as i was peeling it.No hard was done, was able to grab and remove the whole thing.The red handle just completely broke off the sheath on the one side".Picc nurse reported that the picc was a very smooth insertion, nothing out of the ordinary.When she snapped the red handles apart and started pulling it didn' t feel abnormal.Reports she only noticed because she looked at the sheath after removal and one side was not there.Looked down and it was still mostly in the arm.There was maybe 1/4 inch external so she grabbed it and pulled it out.".
Event or Problem Description
It was reported "picc nurse reported the following "placed a dl picc and the peel-away sheath broke apart as i was peeling it.No hard was done, was able to grab and remove the whole thing.The red handle just completely broke off the sheath on the one side".Picc nurse reported that the picc was a very smooth insertion, nothing out of the ordinary.When she snapped the red handles apart and started pulling it didn¿t feel abnormal.Reports she only noticed because she looked at the sheath after removal and one side was not there.Looked down and it was still mostly in the arm.There was maybe 1/4 inch external so she grabbed it and pulled it out.".
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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of an improper peel is confirmed and appears to be manufacturing related.One 5 fr microez microintroducer was returned for evaluation.The grey sheath was returned fully peeled.One of the red tabs was fully detached from the proximal end of the sheath material.Microscopic observation of the detached tab did not reveal evidence of tearing from the sheath material.The sheath material did not appear to have been bonded consistently to the tab material.Since the bonding of the sheath to the tab may have been a contributing factor to the reported event, the complaint is confirmed to be manufacturing related.Bd is working closely with the manufacturing facility to prevent reoccurrence of the reported event.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERPICC PROVENA SOLO 5F DL FT MAX BARRIER PLUS KIT
• 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14251639
• Report Number: 3006260740-2022-01588
• Device Sequence Number: 4285983
• Product Code: LJS
• UDI-Device Identifier: 00801741154904
• UDI-Public: (01)00801741154904
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2022

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: S1295108FD2
• Device Lot Number: REFX2578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown