MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER, 18G 10CM; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	M118100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/06/2018
Type of Reportable Event	Serious Injury
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 of a powerglide luer detachment was confirmed and the cause appeared to be manufacturing-related.The product returned for evaluation was five photographs depicting an 18ga x 10cm powerglide midline catheter.The first two photographs depicted the luer adapter and over-mold.The catheter appeared to be detached from the over-mold.The remaining three photographs depicted a catheter tube.Blood residue was evident within the photograph.The proximal end of the catheter appeared to be detached from the luer/over-mold.The proximal end of the catheter appeared to be the manufacture end.The catheter depicted in the photographs appeared to have become detached from the over-mold.Such a detachment can occur if the catheter is not fully inserted on the core pin during the molding process.The photographs will be submitted to the manufacturing site for further evaluation.A lot history review (lhr) of recp2382 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the insertion of the midline was successful with no issues.Directly after insertion, the nurse lifted the catheter at the hub to place a statlock and heard a pop.The facility stated that, ¿the pop sound is assumed to be the hub separating from the catheter itself.¿ the patient had to go to ir to have product removed.They also noted that they put a tourniquet on the patient to "keep catheter from migrating." no patient injury reported.

• Brand Name: POWERGLIDE MIDLINE CATHETER, 18G 10CM
• 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: 7561269
• Report Number: 3006260740-2018-01181
• Device Sequence Number: 11434757
• Product Code: FOZ
• UDI-Device Identifier: 00801741038105
• UDI-Public: (01)00801741038105
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K133856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: M118100
• Device Catalogue Number: M118100
• Device Lot Number: RECP2382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1