MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 3 OZ. EAR SYRINGE BULK 150

Catalog Number 0935830

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

Patient Problem No Information (3190)

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.

Event Description

It was reported that a bug came out of the syringe once it was filled with saline.Per additional information received, it was reported that the ear syringe was filled with saline and when used to flush out the surgical incision, a bug came out of ear syringe.The staff stated that there was no bug in the saline in the bowl prior to filling the syringe.

Manufacturer Narrative

The reported event could not be confirmed.The photo sample evaluation was inconclusive.The foreign material (insect) was on a gauze pad, with no bard product included in the photographed sample provided.Therefore, the foreign material cannot be evaluated in terms of proximity to a bard manufactured product.Based on the investigation findings, current manufacturing controls are considered adequate, as to detect and segregate any nonconforming unit.The event described could not be confirmed as a manufacturing related issue.The potential root causes of the reported event include defective/contaminated components from supplier and not following the production area cleaning procedure.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A review of the case label was conducted, and the case label contained all required markings and product/manufacturer information.(b)(4).

Event Description

It was reported that a bug came out of the syringe once it was filled with saline.It was later reported that the ear syringe was filled with saline and when used to flush out the surgical incision, a bug came out of ear syringe.The staff stated that there was no bug in the saline in the bowl prior to filling the syringe.

Manufacturer Narrative

The reported event could not be confirmed.The photo sample evaluation was inconclusive.The foreign material (insect) was on a gauze pad, with no bard product included in the photographed sample provided.Therefore, the foreign material cannot be evaluated in terms of proximity to a bard manufactured product.Based on the investigation findings, current manufacturing controls are considered adequate, as to detect and segregate any nonconforming unit.The event described could not be confirmed as a manufacturing related issue.The potential root causes of the reported event include defective/contaminated components from supplier and not following the production area cleaning procedure.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A review of the case label was conducted, and the case label contained all required markings and product/manufacturer information.(b)(4).

Event Description

It was reported that a bug came out of the syringe once it was filled with saline.It was later reported that the ear syringe was filled with saline and when used to flush out the surgical incision, a bug came out of ear syringe.The staff stated that there was no bug in the saline in the bowl prior to filling the syringe.

• Brand Name: 3 OZ. EAR SYRINGE BULK 150
• Type of Device: EAR SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6780035
• MDR Text Key: 82666293
• Report Number: 1018233-2017-04167
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 10801741075992
• UDI-Public: (01)10801741075992
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other,user facili
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0935830
• Device Lot Number: BMBRAM04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/19/2017
• Initial Date FDA Received: 08/09/2017
• Supplement Dates Manufacturer Received: 11/08/2017; 01/11/2018
• Supplement Dates FDA Received: 11/09/2017; 01/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1