MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO® CATHETER 4F SL 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2019
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 reds3909 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the valve wouldn¿t work unless they put the wire back into the valve.12/6/2019- additional information from facility stated, "placed in left basilic vein, one attempt, easily inserted.Picc was tested prior to insertion with tray set up able to flush and aspirate prior to insertion.Placed picc easily on one attempt, easily inserted, flushed easily, sherlock tracked it into the svc and confirmed correct placement per ecg, (blood did come back as note in the external part of picc, and after picc in place and guidewire removed, flushed easily but unable to aspirate, pulled out to 10 cm, still not able to aspirate, changed caps, flushed total of 10 ml x 10 different positioning of patient, to no avail, unable to aspirate back any blood, reinserted guidewire through the external valve and went only in about 6 cm and blood came back while guide wire was still in.But once wire was removed, again to no avail , picc would not aspirate back.Repeated this again, only able to aspirate when i put guidewire back into the picc and once past the external valve blood came back.The guidewire was removed and then unable to aspirate blood back.Picc remove, had to restick patient and then able to place new picc easily, went same pathway, able to verify again with ecg in proper position and able to flush and aspirate back the whole time.".
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, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a valve issue is unconfirmed since the problem could not be reproduced.The returned product was one 4 fr powerpicc solo catheter and a product label with lot: reds3909.The catheter extended up to the 47 cm depth marker.A microscopic observation revealed no apparent damage to the solo valve.No evidence of residual material contributing to the malfunction of the valve was observed.The catheter was flushed with water using a 12 ml syringe.The catheter was patent to infusion and aspiration.Since no functional issues were observed during testing of the sample, the complaint could not be confirmed.A lot history review (lhr) of reds3909 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the valve wouldn't work unless they put the wire back into the valve.12/6/2019- additional information from facility stated, "placed in left basilic vein, one attempt, easily inserted.Picc was tested prior to insertion with tray set up able to flush and aspirate prior to insertion.Placed picc easily on one attempt, easily inserted, flushed easily, sherlock tracked it into the svc and confirmed correct placement per ecg, (blood did come back as note in the external part of picc, and after picc in place and guidewire removed, flushed easily but unable to aspirate, pulled out to 10 cm, still not able to aspirate, changed caps, flushed total of 10 ml x 10 different positioning of patient, to no avail, unable to aspirate back any blood, reinserted guidewire through the external valve and went only in about 6 cm and blood came back while guide wire was still in.But once wire was removed, again to no avail , picc would not aspirate back.Repeated this again, only able to aspirate when i put guidewire back into the picc and once past the external valve blood came back.The guidewire was removed and then unable to aspirate blood back.Picc remove, had to restick patient and then able to place new picc easily, went same pathway, able to verify again with ecg in proper position and able to flush and aspirate back the whole time.".

• Brand Name: POWERPICC SOLO® CATHETER 4F SL 3CG
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9496929
• Report Number: 3006260740-2019-03943
• Device Sequence Number: 11284246
• Product Code: LJS
• UDI-Device Identifier: 00801741188091
• UDI-Public: (01)00801741188091
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2020

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 Expiration Date: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: CK000930
• Device Lot Number: REDS3909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/29/2019
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 81