MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 70CC PISTON SYRINGE WITH CATHETER TIP, LUER ADAPTER AND CAP; IRRIGATION SYRINGE

Catalog Number	0038470
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/26/2019
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.
Event or Problem Description
It was reported that the cap on the tip was missing.
Event or Problem Description
It was reported that the cap on the tip was missing.Per additional information received from the investigator on 26sep2019, the cap is a removable piece that is placed in the syringe tip.
Additional Manufacturer Narrative
The reported event was confirmed.Visual evaluation of the sample noted one opened unused piston syringe.No cap(cm1880) was noted to be on the syringe tip, but an adaptor was included within the syringe barrel s intended.Missing components are not allowed per procedure.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be error of inspector.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "caution: secure tip tightly prior to use." correction: d4.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.

• Brand Name: 70CC PISTON SYRINGE WITH CATHETER TIP, LUER ADAPTER AND CAP
• Common Device Name: IRRIGATION SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9100033
• Report Number: 1018233-2019-05835
• Device Sequence Number: 398436
• Product Code: KYZ
• UDI-Device Identifier: 00801741049323
• UDI-Public: (01)00801741049323
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2019

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 Expiration Date: 02/28/2022
• Device Catalogue Number: 0038470
• Device Lot Number: NGBP2237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1