MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 3F SL MBPLUS; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	Swelling (2091)
Date of Event	09/16/2020
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 reep1767 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "possible micro fracture internal length 1-3 cm proximal to insertion site with 3fr sl powerpicc".Additional info.Received 09/18/2020: "9/16-right basilic 3fr sl picc placed @ bedside without difficulty, no adverse events during procedure, no complaints of discomfort from patient during line placement.One hour post line placement, iv antibiotic infusion was started using infusion pump.Patients right arm 6-8 cm distal to insertion site began to swell which created some patient discomfort.Nurse was notified by patient, as pump did not alarm.Nurse noted the swelling and stopped infusion.Infusion was restarted at a slower rate.Swelling appeared even when infusion was decreased.9/17-vat notified and asked to assess site.Us doppler ordered to r/o thrombus which was negative, prior to contacting vat.There was noted swelling compared to left arm even after infusion had been on hold for 4+ hours.Vat collaborated with provider, bedside nurse, and patient.Line removed and saved for evaluation." "was there patient harm reported?: no harm but delay in discharge.".
Event or Problem Description
It was reported "possible micro fracture internal length 1-3 cm proximal to insertion site with 3fr sl powerpicc" additional info.Received 09/18/2020: "9/16-right basilic 3fr sl picc placed @ bedside without difficulty, no adverse events during procedure, no complaints of discomfort from patient during line placement.One hour post line placement, iv antibiotic infusion was started using infusion pump.Patients right arm 6-8 cm distal to insertion site began to swell which created some patient discomfort.Nurse was notified by patient, as pump did not alarm.Nurse noted the swelling and stopped infusion.Infusion was restarted at a slower rate.Swelling appeared even when infusion was decreased.9/17-vat notified and asked to assess site.Us doppler ordered to r/o thrombus which was negative, prior to contacting vat.There was noted swelling compared to left arm even after infusion had been on hold for 4+ hours.Vat collaborated with provider, bedside nurse, and patient.Line removed and saved for evaluation." "was there patient harm reported?: no harm but delay in discharge.".
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, 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 a leaking catheter was unconfirmed because the problem could not be reproduced.The product returned for evaluation was one 3fr s/l provena powerpicc catheter.Usage residues were observed throughout the sample.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion and aspiration with no observed leaks.No leaks were observed during sustained (>15 seconds) hydraulic pressurization of the sample.Microscopic inspection of the sample did not reveal any damage or evidence of leakage.No damage or deficiencies were discovered during evaluation of the returned sample.Consequently this complaint is unconfirmed at this time.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERPICC PROVENA 3F SL MBPLUS
• 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
• MDR Report Key: 10659357
• Report Number: 3006260740-2020-20046
• Device Sequence Number: 17105038
• Product Code: LJS
• UDI-Device Identifier: 00801741155130
• UDI-Public: (01)00801741155130
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• 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,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2020

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: S1173108D5
• Device Lot Number: REEP1767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 12/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Weight: 91