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, as the device was discarded after the event occurred.A lot history review (lhr) of rebt2073 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the sales rep that the facility reported having a picc line that was leaking from the red hub that connected to the extension leg.The sales rep stated that there was no visible crack.It was reported that only one leg was used, as they did not need the dual lumen and the line was pulled upon completion of therapy.No reported patient injury.
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 leak at the hub was inconclusive because no sample was returned to bas for evaluation.Based on the description of the reported event, possible contributing factors include flexural fatigue, sharp instrument damage, and material choice; however, the lack of a returned sample prevented both confirmation of the reported event and identification of a root cause(s).Consequently, this complaint is inconclusive at this time and the reported event could not be confirmed as a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of rebt2073 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the sales rep that the facility reported having a picc line that was leaking from the red hub that connected to the extension leg.The sales rep stated that there was no visible crack.It was reported that only one leg was used, as they did not need the dual lumen and the line was pulled upon completion of therapy.No reported patient injury.

• 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: 7118125
• Report Number: 3006260740-2017-02234
• Device Sequence Number: 13902993
• Product Code: LJS
• UDI-Device Identifier: 00801741130120
• UDI-Public: (01)00801741130120
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• 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 Catalogue Number: S1274108
• Device Lot Number: REBT2073
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/28/2017
• Initial Report FDA Received Date: 12/14/2017
• 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