MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 23 CM 14.5 FR HEMOSTAR STANDARD KIT; BLOOD ACCESS AND ACCESSORIES

Model Number 5833730

Device Problems Break (1069); Sticking (1597)

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

Event Date 04/20/2017

Event Type  malfunction  

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 initial complaint appeared to be a non-reportable occurrence.Once the sample was returned and evaluated it was determined that a reportable event had occurred.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 stuck guidewire was confirmed and the cause appears to be use related.The product returned for evaluation was a 0.038" x 70cm stainless steel guidewire within an 18ga x 2.75" introducer needle.The investigation findings are consistent with damage caused by retraction of the guidewire against the bevel of the introducer needle.The returned product sample was evaluated and the wire was confirmed to be firmly lodged within the introducer needle.Additionally, it appeared that the inner core wire had broken which allowed the outer coil wire surrounding it to unravel.The wire was forcefully withdrawn from the needle and subsequently examined.Biological material was seen on the wire and appeared to have contributed to the observed guidewire fracture as retraction of the wire together with the biological material could have caused the pieces to become stuck.Microscopic examination of the fracture sites revealed the following: ¿ damage to the inside edge of the introducer needle which can occur if the guidewire is forcefully retracted against the needle, damaging the shape of the sharpened bevel ¿ distinct regions of tightly coiled vs loosely coiled guidewire which transitioned at the location of the biological material.The wire and needle were both measured to be within specification and examination of the wire and needle revealed no potential damage/defect related to manufacture of the product.Normal movement of the guidewire is away from the sharpened bevel and will not damage the wire.If the guidewire direction is reversed, the guidewire is then pulled against sharp edge of the needle bevel and can cause shearing damage, or in the case of the returned sample lodged biological material causing interference between the two components.The product instruction for use (ifu) contains the following information which may be relevant to this type of event, "if the microintroducer guidewire must be withdrawn while the needle is inserted, remove both the needle and wire as a unit to prevent the needle from damaging or shearing the guidewire.¿ a lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

The guidewire was reportedly stuck with the needle guide.On (b)(6) 2017 - per the engineering tech, the sample received has a broken core wire.

• Brand Name: 23 CM 14.5 FR HEMOSTAR STANDARD KIT
• Type of Device: BLOOD ACCESS AND ACCESSORIES
• 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: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6692449
• MDR Text Key: 79516540
• Report Number: 3006260740-2017-00991
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741013409
• UDI-Public: (01)00801741013409
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K051748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5833730
• Device Catalogue Number: 5833730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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