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

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/17/2018
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebt2073 showed four other similar product complaint(s) from this lot number.
Event or Problem Description
The facility reported the night shift was called last night for a defective picc.On arrival vast it was found that the port was "hanging by a thread".It was stated when the nurse pulled it out, the end broke off.
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 is confirmed; however the cause is unknown.One 4 fr dual lumen powerpicc provena was returned for evaluation.An initial visual observation showed the purple luer connector hub was detached from the extension tubing and a portion of the extension tubing remained in the distal end of the luer connector.Use residue was observed throughout the sample and a kink was observed in the catheter at the 2 cm depth marker.The ink at the 2 cm depth marker as well as the ink on the extension legs was observed to be worn and faded.Clamping impressions were also observed on both extension legs.A microscopic observation revealed the fracture surface of the break in the purple lumen was rough and exhibited cracks/fissures and beach marks, which are indicative of material fatigue.The tubing material of both lumens was observed to be attached to the luer connector at irregular points along the tubing¿s circumference and cracking appeared to have initiated at one or more of these points in both lumens.A lot history review (lhr) of rebt2073 showed four other similar product complaint(s) from this lot number.
Event or Problem Description
The facility reported the night shift was called last night for a defective picc.On arrival vast it was found that the port was "hanging by a thread".It was stated when the nurse pulled it out, the end broke off.

• 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: 7250187
• Report Number: 3006260740-2018-00161
• Device Sequence Number: 16364474
• 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
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2018

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 Model Number: N/A
• Device Catalogue Number: S1274108
• Device Lot Number: REBT2073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 02/07/2018
• Supplement Report FDA Received Date: 03/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1