MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGROSHONG CATHETER 5F FULL TRAY (SINGLE-LUMEN) (55CM); PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/01/2017
Type of Reportable Event	Serious Injury
Additional 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 for evaluation.A lot history review (lhr) of rezl0430 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the picc was placed in the patient's left upper arm on (b)(6) 2017.It was discontinued on (b)(6) 2017 and noted to be only 10 cm in length.Subsequent chest x-ray revealed the fractured picc located in the left axillary vein running to the right atrium.The patient was transferred to another facility where she underwent successful removal on (b)(6) 2017 and discharged on (b)(6) 2017.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency 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 a break in the powergroshong picc was confirmed, and the cause was determined to be use related.One 5fr s/l powergroshong picc was returned for investigation.The catheter was received in two sections, but was incomplete.The distal section of the catheter was not returned for investigation.A microscopic examination revealed evidence that was consistent with a sharp instrument cut between the 48 and 49cm depth marks.Evidence of a break in the catheter tubing was observed between the 34 and 35 cm depth marks.It appeared that the break initiated at a point where the catheter was kinked.Approximately one half of the outside edge was rounded at the broken end of the catheter.Multiple semi-circumferential creases were observed in the returned segments of tubing, which are consistent with kinks in the groshong.The edges along the creases were rounded.The characteristics observed in the catheter indicate that the catheter was kinked or flexed during use.Flexural fatigue occurs due to cyclic kinking of the catheter tube during use in which physiological, placement, usage, and mechanical factors may gradually form a crack(s) in the catheter.No defects related to the manufacturing process were noted on the complaint sample.Reference (b)(4) for additional information related to this type of complaint.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of rezl0430 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the picc was placed in the patient's left upper arm on (b)(6) 2017.It was discontinued on (b)(6) 2017 and noted to be only 10cm in length.Subsequent chest x-ray revealed the fractured picc located in the left axillary vein running to the right atrium.The patient was transferred to another facility where she underwent successful removal on (b)(6) 2017 and discharged on (b)(6) 2017.

• Brand Name: POWERGROSHONG CATHETER 5F FULL TRAY (SINGLE-LUMEN) (55CM)
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6832687
• Report Number: 3006260740-2017-01447
• Device Sequence Number: 13467856
• Product Code: LJS
• UDI-Device Identifier: 00801741028540
• UDI-Public: (01)00801741028540
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K063848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2017
• Device Model Number: N/A
• Device Catalogue Number: 7918508
• Device Lot Number: REZL0430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 08/30/2017
• Supplement Report FDA Received Date: 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1