MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SYRINGE IRRIGATION BULK / CLEAN, 50ML; BULB SYRINGE

Catalog Number 0935280

Device Problems Break (1069); Material Fragmentation (1261); Loose or Intermittent Connection (1371)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/15/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the bulb syringe came apart.The customer alleged that fragments from the green bulb became loose and may have ended up in the surgical site.Per additional information received, the patient was undergoing a lysis of adhesions and small bowel resection procedure.A wound irrigation was being performed at the time of the incident.There were confirmed pieces of the bulb in the surgical wound which were retrieved with irrigation.There was no delay in procedure.There was no harm to the patient and the fragments were removed.

Manufacturer Narrative

The reported issue was confirmed as cause unknown.During the visual inspection, the green bulb was found disconnected from the syringe that bulb.Further evaluation noted that the bulb had a flash attached to green bulb neck.Per the functional evaluation; the green bulb was assembled once more in the syringe.The bulb of syringe was squeezed and water suctioned, after squeezing the bulb, the water was irrigated, this was repeated twice and no disconnections were noted during this test.The green bulb and syringe were evaluated dimensionally and the dimensions were found within specification.No additional flash material was observed during the functional evaluation of the returned syringe.The device worked as intended after being re-assembled.The exact mechanism of the reported failure cannot be conclusively determined as the syringe worked without any difficulties when it was functionally challenged.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "irrigation syringe bulb type non sterile irrigation syringe after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.Caution: federal (usa) law restricts this device to sale by or on the order of a physician.Do not resterilize this is a single use device.Do not re-sterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient." correction: concomitant medical products and device evaluated by mfr.

Event Description

It was reported that the bulb syringe came apart.The customer alleged that fragments from the green bulb became loose and may have ended up in the surgical site.Per additional information received, the patient was undergoing a lysis of adhesions and small bowel resection procedure.A wound irrigation was being performed at the time of the incident.There were confirmed pieces of the bulb in the surgical wound which were retrieved with irrigation.There was no delay in procedure.There was no harm to the patient and the fragments were removed.

• Brand Name: SYRINGE IRRIGATION BULK / CLEAN, 50ML
• Type of Device: BULB SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7341198
• MDR Text Key: 102877130
• Report Number: 1018233-2018-00803
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 10801741051378
• UDI-Public: (01)10801741051378
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 0935280
• Device Lot Number: NGBX2194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Date Manufacturer Received: 05/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1