MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 WOUND DRAINAGE; VACUUM TUBING

Device Problems Decrease in Suction (1146); Suction Problem (2170)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

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 hose was not suctioning.No medical intervention reported.

Event Description

It was reported that the hose was not suctioning.No medical intervention reported.

Manufacturer Narrative

The reported event is inconclusive as no sample was returned for evaluation.A potential root cause could be due to the ¿dimensions not specified correctly (including id and od)¿.The lot number is unknown; therefore, the device history record could not be reviewed.The 16vh is not sold with an ifu as it is an accessory of dd15.Therefore the ifu of dd15 was reviewed and found to be adequate as it states " place the collection canister (c) in the drydoc¿ vacuum station base and press down firmly on the lid.Attach the 16 ¿ vacuum tubing (d) to the drydoc¿ vacuum station connector port (e) and the connector port labeled ¿vacuum¿ (f) on the collection canister lid." note:the letters correlate to a diagram within the ifu.Correction: d2 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.H3 other text : the device was not returned.

• Brand Name: WOUND DRAINAGE
• Type of Device: VACUUM TUBING
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9244227
• MDR Text Key: 175075923
• Report Number: 1018233-2019-06828
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1