MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER PROVENA 5F TL 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 Consequences Or Impact To Patient (2199)
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 reds1333 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that when the rn was placing a picc she had trouble with one of the longer (10cm) introducers.It was stated the inner cannula came loose as the rn was attempting to slide over the wire and into the vein.The rn didn't realize it had done this until it would not push in and she saw that the outer part had started to push against the skin without the rigid inner part, causing it to start to tear and push up.Rn had to get a new introducer to finish.
Additional Manufacturer Narrative
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 difficulty inserting a microintroducer is confirmed; however, the exact cause is unknown.One 5.0 fr 10 cm microintroducer was returned for evaluation.An initial visual observation showed use residue on the returned sample.The tip of the introducer sheath was observed to be damaged.The entire length of the shaft of the microintroducer was observed to be slightly curved.The dilator was observed to be returned securely screwed onto the introducer sheath handle.A microscopic observation revealed the edge of one side of the sheath tip was damaged and the material was crumpled and appeared to have been pulled inward.The dilator tip was observed to be undamaged.While the exact cause of the observed damage is unknown, possible contributing factors include insertion technique, too small of an incision, and incomplete/improper connection between the dilator and introducer sheath.----------------------------------------------------------------------------------------------------- reynosa evaluation complaint due to ¿difficulty inserting a microintroducer¿ was confirmed, but the exact cause remains unknown.According with the photo evaluation performed at reynosa facility and gross / microscopic visual evaluation and functional testing performed at vad lab it was concluded that the gray distal end sheath was found to be damaged on its radius tip causing difficulty to advance into the patient while using.This kind of damage could be caused during the manufacturing process; however 100 % inspection under magnification is performed in all devices before final release.In the other hand, risks of damages could be caused during clinical procedure taking in mind the condition of the received sample.Storage conditions also were considered and verified.Therefore, as the definitive root cause of this damage could not be determined the cause of this condition remains unknown.A lot history review (lhr) of reds1333 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that when the rn was placing a picc she had trouble with one of the longer (10cm) introducers.It was stated the inner cannula came loose as the rn was attempting to slide over the wire and into the vein.The rn didn't realize it had done this until it would not push in and she saw that the outer part had started to push against the skin without the rigid inner part, causing it to start to tear and push up.Rn had to get a new introducer to finish.

• Brand Name: POWERPICC SOLO CATHETER PROVENA 5F TL 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: 9285376
• Report Number: 3006260740-2019-03456
• Device Sequence Number: 13484631
• Product Code: LJS
• UDI-Device Identifier: 00801741163296
• UDI-Public: (01)00801741163296
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2019

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: 07/31/2020
• Device Model Number: N/A
• Device Catalogue Number: CK000869
• Device Lot Number: REDS1333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 12/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1