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

Model Number N/A

Device Problems Loss of or Failure to Bond (1068); Detachment of Device or Device Component (2907)

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

Event Date 12/06/2021

Event Type  malfunction  

Event Description

It was reported the "statlock peeled off the adhesive plate." it was stated, "safety issue: dislocation of picc line possible".

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

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 batch history, applicable previous investigation(s), applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a detached retainer on a statlock device was confirmed and appears to be related to the manufacturing process.The products returned for evaluation were two tricot picc plus catheter stabilization statlock devices.One was received used while the other was in its unopened packaging.The used sample had the liner removed and usage residue was seen on the tacky side of the device.The tricot pad had partially separated from the retainer.Microscopic examination of the used sample revealed adhesive residue on the back of the retainer and an impression in the tricot material, where the retainer had been assembled.No tearing was noted on the tricot pad and no pieces of the pad were noted to be adhered on the retainer where the retainer had detached from the pad.This may indicate that the adhesion between the pad and the retainer was insufficient.The unused sample appeared unremarkable to gross visual examination.When pressure was applied to the tricot pad, around the base of the retainer, no separation of the retainer was noted.The retainer on the unused sample was forcefully detached by the investigator.This unused sample appeared similar to the used sample under macroscopic examination, with evidence of adhesive around the perimeter of the retainer and an impression within the tricot material.As the returned sample showed evidence of an insufficient bond, possible contributing factors could include an insufficient amount of adhesive, adhesive in an incorrect location, lack of primer, or an improper cure of the adhesive.Bd is working closely with manufacturing to help prevent recurrence of the reported event.Use related conditions (e.G., tensile damage) may have also contributed to the retainer becoming partially detached.A lot history review (lhr) of jufs1059 showed no other similar product complaint(s) from this lot number.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported the "statlock peeled off the adhesive plate." it was stated, "safety issue: dislocation of picc line possible.".

• Brand Name: STATLOCK SLIDING POST TRICOT CRESCENT PAD INCLUDES SKIN PREP
• Type of Device: DEVICE, INTRAVASCULAR CATHETER SECUREMENT
• 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: 13003455
• MDR Text Key: 282268030
• Report Number: 3006260740-2021-05285
• Device Sequence Number: 1
• Product Code: KMK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: JUFS1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/14/2021
• Supplement Dates Manufacturer Received: 02/24/2022
• Supplement Dates FDA Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2021
• 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