MAUDE Adverse Event Report: BARD ACCESS SYSTEMS COOK UNIV PLS II 6-8.5FR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number CKUPD68

Device Problem Material Integrity Problem (2978)

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

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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of juayf373 showed no other similar product complaint(s) from this lot number.Device not returned at this time.

Event Description

It was reported by the distributor that they have a few statlock that were used with their ult catheters.They report that the statlock is not staying closed.It is unknown how long the statlock was in use.There was no reported patient harm.

Manufacturer Narrative

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 that the statlock retainer would not stay closed was confirmed.It was possible to replicate the complaint if the retainer was partially latched.The cause of the reported complaint was unknown due to unknown use technique.One statlock stabilization device for a 6-8.5fr cook catheter was returned for investigation.The adhesive substrate was stuck to the packaging of an 8.5fr cook multipurpose drainage catheter.Residue was observed on the retainer, which indicates that the device may have been used.A microscopic examination revealed deformation from use in the retaining edge where the barbs latch in the closed position.A functional test revealed that the barbs on the retainer would partially latch if not fully pushed closed.With the barbs partially latched, the retainer door could be forced open.Once fully closed and latched, the retainer would not open.The cause of the reported event could be associated with not fully closing the retainer.The returned sample was forwarded to the manufacturing facility for review.Mfg conclusion - rp 2/16/2018: complaint for the statlock is not staying closed is confirmed due to product evaluation of the sample returned despite retainer remained closed and needed to be disengaged manually to open.Furthermore, cracking at the locking bar and deformation are probably related to usage of the product; this event is most likely related to a user/usage factor.A lot history review (lhr) of juayf373 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by the distributor that they have a few statlock that were used with their ult catheters.They report that the statlock is not staying closed.It is unknown how long the statlock was in use.There was no reported patient harm.

• Brand Name: COOK UNIV PLS II 6-8.5FR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• Manufacturer Contact: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 7155359
• MDR Text Key: 96230100
• Report Number: 3006260740-2017-02350
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CKUPD68
• Device Lot Number: JUAYF373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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