MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER FULL KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reby0980 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the extension set included in the powerglide full kit tore/broke at the connection site.No patient harm was reported.No other information was provided.
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 detached male luer adaptor was confirmed, but the cause was unknown.One extension set from a powerglide kit was returned for investigation.The male luer connector was received separate from the pvc tube.Tape residue was observed on the threaded twist cap and the extension set tubing.A line of adhesive from the luer to tube connection was observed around the pvc tube 5.0mm from the distal end of the extension set tubing.The adhesive line shows the insertion depth of the pvc tubing within the proximal end of the male luer adaptor.No mechanical damage was noted on the tubing or male luer adaptor.The outside diameter of the tubing was within spec.Adhesive residue from the manufacturing process was visible on the tubing.It appeared that the product was manufactured correctly.It is possible that the stress applied to the tubing and male luer adaptor during use exceeded the bond strength of the connection.A lot history review (lhr) of reby0980 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the extension set included in the powerglide full kit tore/broke at the connection site.No patient harm was reported.No other information was provided.

• Brand Name: POWERGLIDE MIDLINE CATHETER FULL KIT
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7310403
• Report Number: 3006260740-2018-00331
• Device Sequence Number: 1890600
• Product Code: FOZ
• UDI-Device Identifier: 00801741038112
• UDI-Public: (01)00801741038112
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2018

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: M118101
• Device Lot Number: REBY0980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/28/2018
• Supplement Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 03/02/2018
• Supplement Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1