MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER, 18G 10CM; INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/10/2017
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, 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 powerglide complications was confirmed and the cause appeared to be manufacturing-related.The product returned for evaluation was one 18ga powerglide midline catheter.The sample was received with an inlaid needle.The needle was detached from the housing assembly.The needle bracket was returned detached from the needle.Microscopic inspection of the needle orifice in the needle bracket revealed the presence of adhesive residue.The adhesive at the orifice appeared deformed.Excess adhesive was observed outside of one of the adhesive application holes in the bracket.Adhesive residue was observed on the needle shaft, near the proximal end.Microscopic inspection of the needle shaft revealed scoring marks along the flash port notch.The safety mechanism was deployed over the needle tip successfully and without difficulty.The excess adhesive outside the application site suggested that poor adhesive deposition during device manufacture caused or contributed to the observed detachment of the needle from the bracket.That detachment appeared to have caused the reported safety difficulty, as the safety mechanism was subsequently successfully activated during device evaluation.A lot history review (lhr) of reax1056 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The facility reported to the bard sales representative that the safety mechanism did not engage on the powerglide device, after placement of the catheter.No patient injury reported.

• Brand Name: POWERGLIDE MIDLINE CATHETER, 18G 10CM
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6644541
• Report Number: 3006260740-2017-00784
• Device Sequence Number: 1149498
• Product Code: FOZ
• UDI-Device Identifier: 00801741038105
• UDI-Public: (01)00801741038105(17)181031(10)REAX1056
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2017

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: 10/31/2018
• Device Model Number: N/A
• Device Catalogue Number: M118100
• Device Lot Number: REAX1056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2017
• Initial Report FDA Received Date: 06/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1