MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK PICC PLUS; 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 12/24/2020

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint that the retainers detached from the statlock pads is confirmed and appears to be manufacturing related.The products returned for evaluation were 13 unopened statlock kits and two opened statlock kits.One of the returned opened kits (sample 1) was returned with the retainer still attached to the foam pad.When an attempt was made to remove the retainer from the pad, the retainer appeared to be adhered to the foam pad around the entire perimeter.The foam pad could be seen tearing when the retainer was pulled, indicating that the retainer had been properly adhered to the pad.The other opened kit (sample 2) was received with the retainer completely detached from the foam pad.Only a small amount of the pad had torn in the lower left-hand corner of the retainer.A small amount of adhesive was seen on the retainer in this location but was not visible on the rest of the perimeter of the retainer.The statlocks in both sample 1 and sample 2 appeared unused as the samples were free of residual material and the paper backing had not been removed from the foam pads.The retainers were attached to the pads on all of the unopened statlock devices.The unopened kits were opened, and an attempt was made to lightly manipulate the retainers to see if they easily removed from the statlock pads.Five of the thirteen unopened samples had retainers that easily separated from the foam pad on the bottom edge on at least one side.The samples did not appear to have a full adhesive transfer between the retainer and pad.The other eight unopened samples showed an even adhesive joint between the retainer and the pad.The retainers did not separate easily from the pads.As the device broke prior to use, the root cause is likely manufacturing related.Possible contributing factors could include an insufficient amount of adhesive, adhesive in an incorrect location, or an improper cure of the adhesive.Bd is working closely with manufacturing to help prevent recurrence of the reported event.A lot history review (lhr) of jues2901 showed five other similar product complaint(s) from this lot number.The complaints for this lot number (jues2901) have been reported from the same facility in (b)(6).

Event Description

It was reported that the rigid part of the statlock comes off the plaster.(b)(6) 2021 - six returned devices easily separated from the foam pad.This report addresses the sixth device.

• Brand Name: STATLOCK PICC PLUS
• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 11753751
• MDR Text Key: 248272929
• Report Number: 3006260740-2021-01619
• Device Sequence Number: 1
• Product Code: FOX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• 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: VPPCSPCE
• Device Lot Number: JUES2901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2020
• 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