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

Catalog Number	M118100
Health Effect - Clinical Code	No Information (3190)
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 reav1678 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Per sales representative, facility contact reported that a healthcare professional experienced difficulty placing a powerglide midline catheter.Additional information has been requested but has not been provided.Photo received shows frayed guidewire.
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), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of placement difficulty and an unwound guidewire is confirmed based on the fact that the guidewire appears unraveled in the returned photograph.The cause remains unknown.The sample returned was one photograph of a portion of a device which appears to be a powerglide.Visual observation of the returned photo sample found that it depicts the tip of the needle safety mechanism, an unraveled guidewire, and the white catheter valve/septum and white grip in which the valve sits.The wire was protruding from the end of the needle safety mechanism, as is normal, but the wire¿s outer coils were unraveled and had come away from the tip of the core wire, which is visibly bent at its end.The coiled wire extended into the white catheter valve inside the white housing.Blood residue could be seen on the white grip and inside the safety mechanism.The wire fracture cannot be well examined via the returned photograph, and no physical sample has been returned, and so the cause of breakage cannot be determined.However, it is known that such guidewire breakages can occur when a guidewire is pressed against the needle bevel and/or retracted against it.It is also possible that other sources of mechanical damage, such as during storage or preparation, contributed to this event.
Event or Problem Description
Additional information received: on or around (b)(6) 2016, the physician placed device with some difficulty.The guidewire was unwound like a spring.No patient injury was reported.

• Brand Name: POWERGLIDE MIDLINE CATHETER 18G, 10CM BASIC TRAY
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6205946
• Report Number: 3006260740-2016-00706
• Device Sequence Number: 709975
• Product Code: FOZ
• UDI-Device Identifier: 00801741038105
• UDI-Public: (01)00801741038105(17)180828(10)REAV1678
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 12/02/2016

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: 08/28/2018
• Device Catalogue Number: M118100
• Device Lot Number: REAV1678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2016
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/27/2016
• Supplement Report FDA Received Date: 01/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1