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, at this time, for evaluation.A lot history review (lhr) of rebu1047 showed three other similar product complaints from this lot number.
Event or Problem Description
It was reported that during picc line placement, blood started coming out of the purple lumen even though it was clamped.They clamped it again and then obtained a new catheter to continue with the procedure.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 defective clamp is confirmed; however, the exact cause is unknown.One 4 fr dual lumen powerpicc provena with ecg tls stylet and t-lock assembly inserted was returned for evaluation.An initial visual observation showed use residue on the returned sample.A clamp indentation was observed in the extension tubing of the purple lumen, approximately 2 cm distal to the luer connector.The pinch clamp of the purple lumen was engaged and an attempt was made to flush the purple lumen with a 12 ml syringe of water.Fluid was observed to pass the clamp despite it being engaged.The clamp was repositioned on the purple extension leg multiple times and was found to stop the flow of fluid occasionally, but would fail to stop the flow of fluid at most positions.The pinch clamp on the red lumen was found to function normally and stopped the flow of fluid when engaged.The white labels of both pinch clamps were removed and a microscopic observation revealed no damage on the clamp of the purple lumen.No damage or defects could be seen on the inner wall of the extension tubing.The sample was dissected and measured.Three cross-sections were taken of the extension tubing at about 5.3 cm, 2.5 cm, and 1.2 cm distal to the luer connector.The inner diameter of each cross-section was measured and averaged and each was found to be within specification.The outer diameter of the extension tubing was also measured and was found to be within specification.The distance between the two points of contact of the pinch clamp was measured in both the open and closed position and was found to be within specification in both positions.The failure mode was able to be replicated on the functional clamp of the red lumen of the sample as well as a non-complainant sample by over-extending the hinge of the clamp while opening the clamp; however, plastic deformation was observed in these clamps, and the space between the locking barb and its point of contact was noticeably larger in both clamps that the failure mode was replicated with than in the malfunctioning clamp of the purple lumen.While not enough evidence was found to determine the root cause of the failure of the pinch clamp, the frequency of similar complaints over the past 24 months was found to be well within the frequency boundaries defined in the product fmea.No further action is required because no evidence was found relating to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of rebu1047 showed no other similar product complaint(s) from this lot number.(b)(4).
Event or Problem Description
It was reported that during picc line placement, blood started coming out of the purple lumen even though it was clamped.They clamped it again and then obtained a new catheter to continue with the procedure.No patient injury was reported.

• 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: 7401460
• Report Number: 3006260740-2018-00627
• Device Sequence Number: 18871382
• 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: User Facility
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2018
• Report Date (Section F): 03/14/2018

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: 04/12/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 04/05/2018
• Supplement Report FDA Received Date: 05/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR