MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 5F DL POWERPICC FT, IR 70CM NITI; LONG TERM INTRAVASCULAR CATHETER

Catalog Number	3275355F
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 reaw0716 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Per sales representative, the facility reported that during the procedure on two occasions the peel away sheath would not come apart.It was stated that the tip broke on one due to the "aggressive force" needed to peel it.No patient harm was reported.This report addresses the second event.
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, trend 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 that the tabs on the microintroducer sheath would not split was confirmed, and the cause appears to be manufacturing related.Two 5 fr microintroducers were returned for investigation.The returned samples revealed evidence of use.Blood residue remained on the products.The sheaths had not been split.One of the peel tabs was fractured, which exposed the end of the sheath that had been molded within the red tab.Impressions from what appear to be hemostats were found on the fractured tab.Hemostats were most likely used due to the high peel force required to split the tabs.An attempt was made to split the sheath that had both handles intact, but the tabs were difficult to split.

• Brand Name: 5F DL POWERPICC FT, IR 70CM NITI
• Common Device Name: LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6227310
• Report Number: 3006260740-2017-00002
• Device Sequence Number: 13630909
• Product Code: LJS
• UDI-Device Identifier: 00801741027970
• UDI-Public: (01)00801741027970(17)200229(10)REAW0716
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K051672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2016

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 Expiration Date: 02/29/2020
• Device Catalogue Number: 3275355F
• Device Lot Number: REAW0716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2017
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/04/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2017
• Supplement Report FDA Received Date: 03/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1