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

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 10/06/2020

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), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a stuck blue post is confirmed and was determined to be manufacturing related.One picc plus statlock device with a foam pad and adjustable posts was returned for evaluation.An initial visual observation showed the statlock device was returned without a liner.The right side of the retainer was observed to be detached from the foam pad and poor adhesive coverage was observed on the underside of the retainer of the detached portion.The right blue sliding post was observed to be outside of and wedged underneath its track.A microscopic observation revealed the right retaining bumps were undamaged, which indicates the sliding post was likely misassembled.The investigation was forwarded to the manufacturing facility for further evaluation.Awareness training was performed with the manufacturing operators regarding this complaint, and bd is working closely with the manufacturing facility to prevent recurrence of the reported event.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that fix blue stick on the statlock.A new device was used.1/11/2021- detachment of the retainer was noted on the returned device.

• Brand Name: STATLOCK PICC PLUS SLIDING POST, 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 11280666
• MDR Text Key: 231417662
• Report Number: 3006260740-2021-00219
• Device Sequence Number: 1
• Product Code: FOX
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• 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: VPPCSP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2021
• 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
• Patient Outcome(s): Other