MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ ORAL DISPENSING SYRINGE 1 ML; LIQUID MEDICATION DISPENSER

Catalog Number 305217

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/22/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 2 bd¿ oral dispensing syringes 1 ml experienced no label or missing information which was noted prior to use.The following information was provided by the initial reporter: material no: 305217 batch no: 9232487.Event description: there is supposed to be syringe caps in the bag with the syringes but in both bags there were no caps.There is no expiration date on this item.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 5/1/2020.H.6.Investigation: two opened bags of 1ml oral syringe product were received.One bag was from batch #8208759 and one from batch #9150669 (p/n 305217).The samples were visually evaluated.The labels on the bags were correctly printed per the label drawing on file.There is no expiration printed on this label per design ¿ this is not a defect.Since the bags were opened it could not be confirmed whether the tip cap bag was or was not present in the sealed bags.Neither of the two received bags matched the complaint batch #.Therefore, no defects could be confirmed for batch #9232487 since no samples were received for that batch.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

Event Description

It was reported that 2 bd¿ oral dispensing syringes 1 ml experienced no label or missing information which was noted prior to use.The following information was provided by the initial reporter: material no: 305217, batch no: 9232487.Event description: there is supposed to be syringe caps in the bag with the syringes but in both bags there were no caps.There is no expiration date on this item.

• Brand Name: BD¿ ORAL DISPENSING SYRINGE 1 ML
• Type of Device: LIQUID MEDICATION DISPENSER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10049248
• MDR Text Key: 200980937
• Report Number: 1213809-2020-00303
• Device Sequence Number: 1
• Product Code: KYW
• 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: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305217
• Device Lot Number: 9232487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2020
• Date Manufacturer Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other