MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PROV SP 3F SL MAX; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	S1173108PD
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2018
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 rebz1627 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the picc was placed using the modified seldinger technique into the left cephalic vein.It was stated the hub broke off the lumen.The picc was replaced over exchange wire into the left brachial vein.
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.One 3 fr single lumen powerpicc provena was returned for evaluation.An initial visual observation showed use residue throughout the sample and the ink on the extension leg and molded joint was observed to be slightly worn and faded.A large split was observed in the extension tubing just within the distal end of the luer connector.A needleless injection cap was observed to be attached the luer hub and the pinch clamp 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.A lot history review (lhr) of rebz1627 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the picc was placed using the modified seldinger technique into the left cephalic vein.It was stated the hub broke off the lumen.The picc was replaced over exchange wire into the left brachial vein.
Event or Problem Description
It was reported that the picc was placed using the modified seldinger technique into the left cephalic vein.It was stated the hub broke off the lumen.The picc was replaced over exchange wire into the left brachial vein.
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 tear in the extension leg was confirmed but the exact cause has not been determined.Two photographs of a power injectable extension leg with a purple clamp and purple connector were provided for investigation.The observed section of the catheter is consistent with the implicated product.An injection cap was attached to the purple connector.Residue was observed on the external surface of the extension leg.There was a breach in the extension leg at the distal end of the purple connector.It appeared that the connector was still attached to the extension leg by a portion of the tubing.A lot history review (lhr) of rebz1627 showed no other similar product complaint(s) from this lot number.

• Brand Name: DOT PROV SP 3F SL MAX
• 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: 8028464
• Report Number: 3006260740-2018-03065
• Device Sequence Number: 16488786
• Product Code: LJS
• UDI-Device Identifier: 00801741134104
• UDI-Public: (01)00801741134104
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2019

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 Model Number: S1173108PD
• Device Catalogue Number: S1173108PD
• Device Lot Number: REBZ1627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Initial Date Received by Manufacturer: 10/08/2018
• Supplement Date Received by Manufacturer: 11/13/2018; 03/12/2019
• Initial Report FDA Received Date: 11/01/2018
• Supplement Report FDA Received Date: 11/21/2018; 03/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 YR