MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK PICC PLUS SLIDING POST CRESCENT PAD W/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 07/21/2021

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 appears to be manufacturing related.One picc plus statlock device with a foam pad and adjustable posts, the detached retainer of what appears to be a picc plus statlock device with a foam pad and adjustable posts, and one empty package were returned for evaluation.An initial visual observation showed a few pieces of foam on the bottom side of the underside of the detached retainer.No damage was observed on the intact statlock device.An attempt was made to separate the retainer of the intact statlock sample and while some small tears formed in the foam pad, the retainer was found to be firmly attached to the foam pad.A microscopic observation revealed poor adhesive coverage on the underside of the detached retainer, which likely occurred during the manufacturing process.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.A lot history review (lhr) of juey1089 showed one other similar product complaint(s) from this lot number.

Event Description

It was reported that the plastic part of statlock allegedly found to be broken.There was no reported patient injury.No other information was provided.(b)(6) 2021: the returned sample was found to have a detached retainer.

• Brand Name: STATLOCK PICC PLUS SLIDING POST CRESCENT PAD W/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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12544331
• MDR Text Key: 273740676
• Report Number: 3006260740-2021-04037
• Device Sequence Number: 1
• Product Code: FOX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• 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: JUEY1089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2020
• 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