MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN FECAL MANAGEMENT (DIGNISHIELD); UNKNOWN DIGNISHIELD

Device Problems Break (1069); Deflation Problem (1149); Degraded (1153); Fluid/Blood Leak (1250)

Patient Problems Erythema (1840); Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that the diginishield tubing degraded when the nurse tried to irrigate the system of a patient that was in the intensive area unit.It was noted that when the nurse tried to deflate the balloon there was no water in the bulb.This device had been placed in the patient for less that eight days (inserted on (b)(6) 2019).There was no report of any missing pieces inside of the patient.It was also noted that the buttocks were red and excoriated from stool and zinc oxide was in use during the use of the device.

Manufacturer Narrative

The reported event was confirmed, however, the cause is unknown.Visual evaluation of the photo samples noted one opened (with some original packaging), part of a fecal management device and some associated labeling.Visual inspection of the sample noted that the tubing of the device had broken open at several points, causing leakage of the contained biological detritus.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be, ¿inadequate material selection." the lot number is unknown; therefore, the device history record could not be reviewed.The product catalog number for this device is unknown.Therefore, bd is 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 diginishield tubing degraded when the nurse tried to irrigate the system of a patient that was in the intensive area unit.It was noted that the when the nurse tried to deflate the balloon there was no water in the bulb.This device had been placed in the patient for less that eight days (inserted on (b)(6) 2019).There was no report of any missing pieces inside of the patient.It was also noted that the buttocks were red and excoriated from stool and zinc oxide was in use during the use of the device.

• Brand Name: UNKNOWN FECAL MANAGEMENT (DIGNISHIELD)
• Type of Device: UNKNOWN DIGNISHIELD
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9679321
• MDR Text Key: 178106145
• Report Number: 1018233-2020-00846
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K133251
• 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: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Date Manufacturer Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other