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

Catalog Number PIC0220CE

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a detached retainer is confirmed and was determined to be manufacturing related.Two picc plus statlock kits were returned for evaluation.An initial visual observation showed one of the kits was returned open and one kit was returned sealed.The retainer of the statlock device returned in the open kit was found to be completely detached, and the underside of this detached retainer was observed to be tacky and stuck slightly to the edge of the detached pad.The detached pad was also found to be tacky at this location.The underside of the retainer as well as the pad of the sample returned in the sealed kit were also found to be tacky.A microscopic observation revealed good adhesive coverage on the underside of both retainers; however, strings of adhesive were found on the underside of the retainer of the sealed sample when an attempt was made to remove it from the pad.This suggests that the adhesive between the retainer and pad may not have been fully cured.The investigation has been forwarded to the manufacturing facility for further evaluation, and bd is working closely with the manufacturing facility to prevent recurrence of the reported event.A lot history review (lhr) of juer1322 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (juer1322) have been reported from multiple facilities in (b)(4).

Event Description

It was reported the plastic clamps on the statlock device falls off the band aid so the picc catheter is at risk for sliding out off the patient because it is not fixed.So plastic clamps are not fixed correct on the band aid.No other information was provided.On (b)(6) 2021- two devices were returned.This report addresses the second device.

• Brand Name: STATLOCK SLIDING POST CRESCENT PAD 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 11856200
• MDR Text Key: 252605217
• Report Number: 3006260740-2021-01899
• Device Sequence Number: 1
• Product Code: FOX
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PIC0220CE
• Device Lot Number: JUER1322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2020
• 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