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

Catalog Number	0935830
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: EAR SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6780035
• Report Number: 1018233-2017-04167
• Device Sequence Number: 16536225
• Product Code: KYZ
• UDI-Device Identifier: 10801741075992
• UDI-Public: (01)10801741075992
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other,user facili
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 07/19/2017
• Supplement Date Received by Manufacturer: 11/08/2017; 01/11/2018
• Initial Report FDA Received Date: 08/09/2017
• Supplement Report FDA Received Date: 11/09/2017; 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1