MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POLY PER-Q-CATH CATHETER 4F SINGLE-LUMEN FULL TRAY (WITH MIRCROINTRODUCER); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of recp1673 showed no other similar product complaint(s) from this lot number.Device has not yet been returned for evaluation.
Event or Problem Description
It was reported that a hole was noted in the catheter when preparing the sterile field and flushing catheter.
Additional 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 a hole in the catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 4fr s/l poly per-q-cath catheter.The sample was untrimmed and appeared free of usage residues.The catheter was received with an inlaid stylet with t-lock assembly.A split was observed in the t-lock assembly extension tubing.Microscopic inspection of the split revealed irregular edges.The split edges exhibited irregular and striated fracture surfaces.The split was v-shaped and impressions were observed leading into the split site.The fracture features were consistent with damage caused by contact between the extension tubing and a traumatic instrument.The split shape and impressions was suggestive of the tubing being pinched by a grasping instrument.The product ifu states ¿avoid accidental device contact with sharp instruments and mechanical damage to the catheter material.Use only smooth-edged atraumatic clamps or forceps.¿ a lot history review (lhr) of recp1673 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that a hole was noted in the catheter when preparing the sterile field and flushing catheter.

• Brand Name: POLY PER-Q-CATH CATHETER 4F SINGLE-LUMEN FULL TRAY (WITH MIRCROINTRODUCER)
• 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: 8001969
• Report Number: 3006260740-2018-03018
• Device Sequence Number: 1807244
• Product Code: LJS
• UDI-Device Identifier: 00801741034862
• UDI-Public: (01)00801741034862
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K034019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018

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: 3154108
• Device Lot Number: RECP1673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 86