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

Model Number M118100

Device Problems Detachment Of Device Component (1104); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/06/2018

Event Type  Injury  

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 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
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: tesha udy ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225819
• MDR Report Key: 7561269
• MDR Text Key: 109885435
• Report Number: 3006260740-2018-01181
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741038105
• UDI-Public: (01)00801741038105
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133856
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1