MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SURG. SUCTION/IRRIGATION; UNKNOWN SYRINGE

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

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 while irrigating an orif (open reduction and internal fixation) of an ankle, it was discovered that the asepto had small rings of green plastic inside the bulb.The rings were irrigated into the patient's wound.The surgeon took immediate action by removing the rings from the wound.Fresh irrigation and asepto were obtained and further irrigation of the wound was completed with no further incident.

Event Description

It was reported that while irrigating an orif (open reduction and internal fixation)of an ankle, it was discovered that the asepto had small rings of green plastic inside the bulb.The rings were irrigated into the patient's wound.The surgeon took immediate action by removing the rings from the wound.Fresh irrigation and asepto were obtained and further irrigation of the wound was completed with no further incident.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown therefore the device history record could not be reviewed."sec.801.116 medical devices having commonly known directions: a device shall be exempt from section 502(f)(1) of the act in so far as adequate directions for common uses there of are known to the ordinary individual." correction: brand name.

• Brand Name: SURG. SUCTION/IRRIGATION
• Type of Device: UNKNOWN SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8660614
• MDR Text Key: 146910407
• Report Number: 1018233-2019-02857
• Device Sequence Number: 1
• Product Code: KYZ
• 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: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1