MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK SLIDING POST TRICOT CRESCENT PAD INCLUDES SKIN PREP; STAND, INFUSION

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2022

Event Type  malfunction  

Event Description

It was reported at hematology, there were 2 statlock bandages where the hard pvc piece detaches from the adhesive.This report addresses the first device.

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of jugq2029 showed one other similar product complaint(s) from this lot number.The complaints for this lot number: (jugq2029) have been reported from facility in belgium.

Event Description

It was reported at hematology, there were 2 statlock bandages where the hard pvc piece detaches from the adhesive.This report addresses the first device.

Manufacturer Narrative

Section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample analysis, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of detached retainers is confirmed and was determined to be manufacturing related.Two picc plus statlock devices with tricot pads and adjustable posts were returned for evaluation.An initial visual observation showed use residue on one of the returned samples.The retainer of this sample was found to be almost completely detached from its pad.The bottom left corner of the retainer of the other returned sample was also found to be detached from its pad.The pads and the undersides of the retainers of the returned samples were observed to be somewhat tacky.A microscopic observation revealed somewhat poor adhesive coverage on the underside of the detached retainers.Strings of adhesive were observed between the pad and the retainer of both samples, suggesting that the adhesive did not cure correctly.The investigation was forwarded to the manufacturing facility for further evaluation, and bd is working closely with the manufacturing facility to prevent recurrence of the reported event.

• Brand Name: STATLOCK SLIDING POST TRICOT CRESCENT PAD INCLUDES SKIN PREP
• Type of Device: STAND, INFUSION
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15712043
• MDR Text Key: 307566418
• Report Number: 3006260740-2022-04233
• Device Sequence Number: 1
• Product Code: FOX
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PIC0220CE
• Device Lot Number: JUGQ2029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2022
• 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
• Patient Outcome(s): Other