MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN SYRINGE

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that graduation printing on the 565 syringes was illegible/incomplete.

Event Description

It was reported that graduation printing on the 565 syringes was illegible/incomplete.

Manufacturer Narrative

The reported event was confirmed, however, the cause is unknown.Visual evaluation of the returned sample noted two opened (without original packaging), unused suction/irrigation syringes.Visual inspection of the sample noted that both received syringes had incomplete graduation markings at various points on the syringe bodies.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be, ¿fading, staining, solvent deterioration." the lot number is unknown; therefore, the device history record could not be reviewed.The product catalog number for this surgical suction/irrigation product is unknown.Therefore, bd is unable to determine the associated labeling to review.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: UNKNOWN SYRINGE
• Type of Device: UNKNOWN SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8842936
• MDR Text Key: 152972583
• Report Number: 1018233-2019-04343
• 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: distributor,other
• Type of Report: Initial,Followup
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Date Manufacturer Received: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1