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

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

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

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of jueu0052 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (jueu0052) have been reported from the same facility in the netherlands.

Event Description

It was reported that when "removing the patches, for 3 patients the lock got loose." this report addresses the third device used.

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), 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.Three picc plus statlock devices with tricot pads and adjustable posts were returned for evaluation.An initial visual observation showed use residue on the returned samples.The retainer of one sample was observed to be completely detached from its pad, and a microscopic observation revealed insufficient adhesive coverage on the underside of the detached retainer.The retainers of the other two samples were observed to be intact, but the right side of each of these retainers was found to detach slightly from the pad when a small amount of force was applied.Strings of adhesive were observed between the retainer and the pad of these two samples.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.

Event Description

It was reported that when "removing the patches, for 3 patients the lock got loose." this report addresses the third device used.

• Brand Name: STATLOCK SLIDING POST TRICOT 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
• MDR Report Key: 11388556
• MDR Text Key: 238616172
• Report Number: 3006260740-2021-00535
• 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,other
• Type of Report: Initial,Followup
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• 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: PIC0220CE
• Device Lot Number: JUEU0052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Date Manufacturer Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other