MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 4F DL MBPLUS (3CG); 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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2022
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 refq1088 showed 4 other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the customer that the picc line kinked on placement.Picc confirmed with ecg on placement; upon placement of dressing, picc unable to flush despite brisk flush/blood return immediately prior.Dressing removed and securacath opened to assess for kink.No notable kink at site.Chest xray taken and tip at superior cavoatrial junction.Line retracted 0.5cm to assess for learned kink in catheter, but none seen.Resistance noted with slight retraction of line, most likely d/t vasospasm.Pt reports feeling anxious with troubleshooting but is generally stoic.Securacath removed and stat lock/steri strips used.Will place heat packs on arm and reassess in a few hours.If catheter continues to have issues, will plan for exchange tomorrow morning.No other information was provided.
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.
Event or Problem Description
It was reported, vat called to troubleshoot picc just exchanged this morning.Upon assessment, picc completely occluded and unable to flush or draw blood.Xray image obtained showing similar kinking of catheter with previous line.Additional information received on (b)(6) 2023: catheter was secured with securacath.Patient being treated for small bowel obstruction with a medical history of jejunal atresia and malrotation s/p ex-lap, resection of jejunal atresia with jejuno-jejunostomy, and ladd's procedure in infancy.No other information was provided.
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 complaint of a kinked catheter was confirmed but the cause is unknown.A single ap radiographic image of the right side of the chest and arm was returned for evaluation of this complaint.The implicated product was a 4fr d/l powerpicc provena catheter.A catheter kink was noted in the catheter near the skin surface.It was reported that flow through the catheter was completely obstructed, which was likely due to the kink.Possible contributing factors could include catheter placement or securement.The ifu states, ¿avoid placement or securement of the catheter where kinking may occur, to minimize stress on the catheter, patency problems or patient discomfort.¿ and ¿avoid sharp or acute angles during implantation which could compromise the patency of the catheter lumen.¿ the report of a kinked catheter has been documented and will be monitored as part of complaint trending.
Event or Problem Description
It was reported, vat called to troubleshoot picc just exchanged this morning.Upon assessment, picc completely occluded and unable to flush or draw blood.Xray image obtained showing similar kinking of catheter with previous line.Additional information received on 2/28/2023: catheter was secured with securacath.Patient being treated for small bowel obstruction with a medical history of jejunal atresia and malrotation s/p ex-lap, resection of jejunal atresia with jejuno-jejunostomy, and ladd's procedure in infancy.No other information was provided.
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.
Event or Problem Description
It was reported, vat called to troubleshoot picc just exchanged this morning.Upon assessment, picc completely occluded and unable to flush or draw blood.Xray image obtained showing similar kinking of catheter with previous line.Additional information received on 2/28/2023: catheter was secured with securacath.Patient being treated for small bowel obstruction with a medical history of jejunal atresia and malrotation s/p ex-lap, resection of jejunal atresia with jejuno-jejunostomy, and ladd's procedure in infancy.No other information was provided.Additional information received 5/25 catheter was inserted 9cm above the antecubital fossa with 4cm left external to the patient.

• Brand Name: POWERPICC PROVENA 4F DL MBPLUS (3CG)
• 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: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16483090
• Report Number: 3006260740-2023-00670
• Device Sequence Number: 7671857
• Product Code: LJS
• UDI-Device Identifier: 00801741154744
• UDI-Public: (01)00801741154744
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/31/2023

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: S1274108D1
• Device Lot Number: REFQ1088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2023
• Supplement Date Received by Manufacturer: 02/28/2023; 05/17/2023; 05/25/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 04/01/2023; 05/23/2023; 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• 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 Age: 14 YR
• Patient Sex: Unknown
• Patient Weight: 43 KG