MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PROV 4F DL FULL 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number	S1274108
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
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 rebu1047 showed three other similar product complaint(s) from this lot number.The complaints for this lot number (rebu1047) have been reported from one facility.
Event or Problem Description
It was reported that when the vas team arrived to assess the patient¿s picc, the patient's dressing had been removed and the lumens were wrapped in an abdominal pad due to leaking.It was noted that it was fractured ¿where the tubing enters into the end portion of the lumens¿ and that the fracture was visible.It was also noted that ¿blood was leaking out.¿ the picc was removed and a sterile dressing was placed.
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 leak is confirmed.An initial visual observation showed use residue throughout the sample and a needleless injection cap was observed to be attached to each luer hub and an end cap was attached to the needless injection cap on the purple lumen.A split was observed in the extension tubing of the purple lumen just within the distal end of the luer connector.The ink on the extension legs was observed to be slightly worn and faded and the pinch clamp of the red lumen was observed to be engaged.A microscopic observation revealed the fracture surface of the split in the extension tubing of the purple lumen was rough and exhibited cracks/fissures and beach marks.
Event or Problem Description
It was reported that when the vas team arrived to assess the patient¿s picc, the patient's dressing had been removed and the lumens were wrapped in an abdominal pad due to leaking.It was noted that it was fractured ¿where the tubing enters into the end portion of the lumens¿ and that the fracture was visible.It was also noted that ¿blood was leaking out.¿ the picc was removed and a sterile dressing was placed.

• Brand Name: DOT PROV 4F DL FULL 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: 7367107
• Report Number: 3006260740-2018-00515
• Device Sequence Number: 2312409
• Product Code: LJS
• UDI-Device Identifier: 00801741130120
• UDI-Public: (01)00801741130120
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2019
• Report Date (Section F): 02/26/2018

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 Catalogue Number: S1274108
• Device Lot Number: REBU1047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 03/23/2018
• Supplement Report FDA Received Date: 02/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR