MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 STATLOCK SL FOLEY, UNKNOWN CODE

Catalog Number UNKNOWN

Device Problems Break (1069); Nonstandard Device (1420); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Burning Sensation (2146); Patient Problem/Medical Problem (2688)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the patient experienced pain and bleeding due to the plastic clip on the statlock which had sheared off the adhesive pad.The patient replaced with another statlock but did not apply skin protectant during usage, which resulted in burning sensation.No medical intervention reported.As per additional information on 28 may 2020, the topical rubbing alcohol was used for the adhesive burn to get dissipated.Also suspected that there must be a pressure on the downstream hose which the patient was not aware that could have caused the failure.

Manufacturer Narrative

The reported event was inconclusive, as no sample returned for evaluation.A potential root cause for this failure mode could be due to ¿inadequate material strength¿.Which resulted in clamp breaks.It was unknown whether the device had met specifications.The product used for the treatment purposes.The device was not returned for evaluation.The lot number was unknown, therefore, the device history record could not be reviewed.The product catalog number for this device was unknown.Therefore, bard was unable to determine the associated labeling to review.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.

Event Description

It was reported that the patient experienced pain and bleeding due to the plastic clip on the statlock which had sheared off the adhesive pad.The patient replaced with another statlock but did not apply skin protectant during usage, which resulted in burning sensation.No medical intervention reported.As per additional information on 28may2020, the topical rubbing alcohol was used for the adhesive burn to get dissipated.Also suspected that there must be a pressure on the downstream hose which the patient was not aware that could have caused the failure.

• Brand Name: STATLOCK SL FOLEY, UNKNOWN CODE
• Type of Device: STATLOCK
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10155555
• MDR Text Key: 195536572
• Report Number: 1018233-2020-03860
• Device Sequence Number: 1
• Product Code: EYJ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1