MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK PICC PLUS; STAND, INFUSION

Catalog Number VPPCSPCE

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of juep3663 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility in (b)(6).

Event Description

It was reported that two devices were found not sticking to adhesive backing.No other information was provided.This report addresses the second device.

Manufacturer Narrative

H11: 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), returned physical samples, applicable fmea documents, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of detachment of the statlock retainer from the foam adhesive pad was confirmed and the cause was determined to be manufacturing related.The product returned for evaluation was two statlock picc plus catheter stabilization devices.One was returned with an opened pouch and another was returned sealed within the original pouch.No traces of product usage were seen on the opened sample.The opened sample was confirmed to contain a statlock retainer which was partially detached from the foam base.Further evaluation of the foam pad and mating retainer base found that adhesive had been consistently applied but did not adequately join the two components.The sealed sample was then opened and inspected and it was determined that adhesive application was likewise consistently applied.Very little force was required to pull the retainer up from the foam pad and the pad did not tear during the action.The fact that the retainer could be easily detached, without tearing the foam pad, confirmed that the bond between the two components was inadequate and that the cause was likely related to the manufacturing process.The sample photographs were then submitted for review and evaluation by the manufacturing facility.Bd is working closely with the manufacturing facility to prevent recurrence of the reported event.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported that two devices were found not sticking to adhesive backing.No other information was provided.This report addresses the second 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
• MDR Report Key: 10979822
• MDR Text Key: 221271668
• Report Number: 3006260740-2020-20829
• Device Sequence Number: 1
• Product Code: FOX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VPPCSPCE
• Device Lot Number: JUEP3663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other