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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by healthcare professional "a triple lumen picc was attempted on a patient in critical care.Vein was accessed with no problem, picc was introduced and threaded into the vein smoothly, with no resistance met until mid-clavicular.Patient was repositioned picc withdrawn slightly and attempted to flush the picc while advancing.Again resistance was met mid-clavicular, at this time picc was not able to be flushed or aspirated for blood return.Due to patients critical statis the picc procedure was to be terminated due to not being able to thread picc to desired location.As picc was being removed at the 45cm external mark resistance was met and the picc was no longer able to be pulled out of patient (8cm remained internal).3cg wire was removed from catheter at this time with no resistance, wire initially seemed to be intact when assessed.Icu resident brought into room to assist picc team with removal, also was met with resistance and unable to remove.Vat recommended vascular surgery and ir be consulted.Dressing applied over picc and site till vascular surgery arrived.Picc team spoke with icu resident for an arm, and chest xray.Cxr done first initially and not wire or picc was noted to cross axilla to chest.Upper arm xray recommended, and vascular surgery was at bedside to also attempt picc removal and was also unsuccessful, but patient to unstable to take to operation room for removal.Upper arm xray done and picc noted to be knotted with rest or 3cg wire within picc (estimated 5cm of wore noted within knot to tip of catheter).¿.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refs0076 showed no other similar product complaint(s) from this lot number.
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 initial report was sent as a serious injury.Upon review of the event it was determined a serious injury did not occurred.This report has been updated to malfunction.
Event or Problem Description
It was reported by healthcare professional "a triple lumen picc was attempted on a patient in critical care.Vein was accessed with no problem, picc was introduced and threaded into the vein smoothly, with no resistance met until mid-clavicular.Patient was repositioned picc withdrawn slightly and attempted to flush the picc while advancing.Again resistance was met mid-clavicular, at this time picc was not able to be flushed or aspirated for blood return.Due to patients critical statis the picc procedure was to be terminated due to not being able to thread picc to desired location.As picc was being removed at the 45cm external mark resistance was met and the picc was no longer able to be pulled out of patient (8cm remained internal).3cg wire was removed from catheter at this time with no resistance, wire initially seemed to be intact when assessed.Icu resident brought into room to assist picc team with removal, also was met with resistance and unable to remove.Vat recommended vascular surgery and ir be consulted.Dressing applied over picc and site till vascular surgery arrived.Picc team spoke with icu resident for an arm, and chest xray.Cxr done first initially and not wire or picc was noted to cross axilla to chest.Upper arm xray recommended, and vascular surgery was at bedside to also attempt picc removal and was also unsuccessful, but patient to unstable to take to ir or or for removal.Upper arm xray done and picc noted to be knotted with rest or 3cg wire within picc (estimated 5cm of wore noted within knot to tip of catheter).¿.

• Brand Name: POWERPICC PROVENA SOLO 5F TL 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: 12839089
• Report Number: 3006260740-2021-04931
• Device Sequence Number: 4510367
• Product Code: LJS
• UDI-Device Identifier: 00801741155222
• UDI-Public: (01)00801741155222
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: S1395108D5
• Device Lot Number: REFS0076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 11/18/2021
• Supplement Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2021
• 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: Required Intervention; Other
• Patient Sex: Unknown