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

Model Number	M122081
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 detached male luer adaptor was confirmed, but the cause was unknown.Two extension sets from what was reported to be a powerglide kit were returned for investigation.The male luer adaptor had separated from each pvc tube.The force required to separate the tubing from the luer adaptor was unknown since the returned samples were already damaged.Evidence of use was noted on one complaint sample, which indicates that the product was damaged while in use.Residue was observed on the pvc tubing and detached connector.The other extension set appeared to be unused.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 rebs1198 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that the adhesive on the extension tubing came apart.No other information was provided.No harm to the patient reported.This file is for second device returned for evaluation.

• 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: 7278608
• Report Number: 3006260740-2018-00235
• Device Sequence Number: 16512970
• Product Code: FOZ
• UDI-Device Identifier: 00801741038150
• UDI-Public: (01)00801741038150
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/16/2018

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: M122081
• Device Catalogue Number: M122081
• Device Lot Number: REBS1198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2018
• Initial Report FDA Received Date: 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1