MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 4F; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/23/2018

Event Type  malfunction  

Manufacturer Narrative

The information provided by bard 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 bard.The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) review is not possible; as no manufacturing lot number has been provided.

Event Description

It was reported there was blood return in catheter when stopper is removed.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of blood backflow was inconclusive because the valve crack pressure could not be measured and the use conditions in which the event was reported to have occurred could not be reproduced.The product returned for evaluation was one 4fr s/l powerpicc solo catheter.Usage residues were observed throughout the sample.A needleless injection cap was attached to the luer adapter.The catheter terminated at the 41cm depth marking.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 both with and without the needleless injection cap attached.The effort required to aspirate was comparable to that required for a similar non-complainant device.The catheter was charged with water and held vertically with the valve facing down and no leakage was observed.Microscopic inspection of the valve revealed adhesive adhered to the valve but no apparent valve damage.The edges of the valve appeared to properly mated.No functional deficiencies were observed during evaluation of the returned sample; however, the valve crack pressure could not be measured to determine if it met performance requirements, nor could the environment in which the event was reported to have occurred be replicated.Consequently this complaint is inconclusive at this time.The presence of usage residue adhered to the valve suggested that residue accumulation during device indwell may have contributed to the reported event.A lot history review (lhr) review is not possible; as no manufacturing lot number has been provided.

Event Description

It was reported there was blood return in catheter when the stopper was removed.No other information was provided.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET 4F
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 7602594
• MDR Text Key: 111749852
• Report Number: 3006260740-2018-01376
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741138973
• UDI-Public: (01)00801741138973
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 2194108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1