MAUDE Adverse Event Report: DAVOL SURGICAL INNOVATIONS -9616067 SL FOLEY SWIVEL SILICONE TRICOT 25BX; STATLOCK

Catalog Number FOL0102

Device Problem Detachment Of Device Component (1104)

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

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.

Event Description

It was reported that the plastic swivel base disconnected from the adhesive pad.

Manufacturer Narrative

Received 1 used statlock adhesive pad only.The reported event was confirmed; however, the exact cause was unknown.The returned sample was visually inspected and it was observed to be attached to the internal wall of a ziploc bag.The quality of the sample was compromised such that it could not be used in the evaluation.The retainer and base was disconnected from the pad and it were not returned for evaluation.Based on the sample condition, the functional testing could not be completed.It was observed that the pad contained residues of adhesive, but the amount of adhesive could not be determined based on the sample condition.Therefore, it was unknown if this complaint was related to the manufacturing process.The potential root causes associated to these risks are: insufficient amount of primer and insufficient amount of adhesive according.Glue selection incompatible with clamp base.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "always secure catheter into the statlock device retainer before applying adhesive pad on skin".(b)(4).

Event Description

It was reported that the plastic swivel base disconnected from the adhesive pad.

• Brand Name: SL FOLEY SWIVEL SILICONE TRICOT 25BX
• Type of Device: STATLOCK
• Manufacturer (Section D): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• 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: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6552626
• MDR Text Key: 74833063
• Report Number: 1018233-2017-02285
• Device Sequence Number: 1
• Product Code: EYJ
• 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: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: FOL0102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2017
• 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