MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PROV SP 4F DL MAX; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number	N/A
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 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 inconclusive, due to poor sample condition.One photograph of the extension legs of what appears to be a 4 fr dual lumen powerpicc provena was returned for evaluation.An initial visual observation of the photograph showed the proximal portion of the catheter, from the bifurcation to the luer connector hubs.Needleless injection caps were observed on the luer connectors of both lumens and blood residue could be seen in the red lumen.Some sort of white dressing and tape was observed on the proximal half of the red lumen which covered the junction of the extension tubing and luer connector.No breaks, splits, or other damage could be seen on the sample in the returned photograph.Possible contributing factors of a leak include sharp instrument damage, material fatigue, and chemical exposure.A lot history review (lhr) of rebt2364 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The facility reported to sales rep that the picc began to leak at the red port and extension leg connection.The picc was removed.No other information is available at this time.No patient injury was reported.
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 inconclusive, due to poor sample condition.One photograph of the extension legs of what appears to be a 4 fr dual lumen powerpicc provena was returned for evaluation.An initial visual observation of the photograph showed the proximal portion of the catheter, from the bifurcation to the luer connector hubs.Needleless injection caps were observed on the luer connectors of both lumens and blood residue could be seen in the red lumen.Some sort of white dressing and tape was observed on the proximal half of the red lumen which covered the junction of the extension tubing and luer connector.No breaks, splits, or other damage could be seen on the sample in the returned photograph.Possible contributing factors of a leak include sharp instrument damage, material fatigue, and chemical exposure.A lot history review (lhr) of rebt2364 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The facility reported to sales rep that the picc began to leak at the red port and extension leg connection.The picc was removed.No other information is available at this time.No patient injury was reported.

• Brand Name: DOT PROV SP 4F DL MAX
• 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: 7065447
• Report Number: 3006260740-2017-02126
• Device Sequence Number: 1079780
• Product Code: LJS
• UDI-Device Identifier: 00801741134326
• UDI-Public: (01)00801741134326
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 02/08/2018

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: S3274108PD
• Device Lot Number: REBT2364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/08/2017
• Supplement Date Received by Manufacturer: 12/28/2017
• Initial Report FDA Received Date: 11/28/2017
• Supplement Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 6 MO