MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE ORAL 3ML AMBER; LIQUID MEDICATION DISPENSER

Catalog Number 305210

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 10/14/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 an unspecified number of syringe oral 3ml amber experienced a mix of product types in a pack which was noted prior to use.The following information was provided by the initial reporter: we have had a delivery of amber syringes, polypropylene, amber barrel and white tip cap where there are mixed lot numbers within the boxes.Our goods in have opened 26 boxes and out of these, four were found to have lot numbers mixed up within each box.The lot number/batch number on the documentation and outer box label is 9024705,the boxes in question had some bags with lot numbers of 9024703 inside one box had 2 bags of incorrect lot number inside.Two boxes had 4 bags of incorrect lot number inside.One box had all 5 bags of incorrect lot number inside.All bags have been returned to their original boxes and the batch has been quarantined.

Manufacturer Narrative

H.6.Investigation: four photos were received and evaluated.The largest quantity of bags displayed in a single photo was five, with three from batch 9024705 (p/n 305210) and two from batch 9024703 (p/n 305210).One photo showed a 500-count label from batch 9024705 (p/n 305210).The incorrect label defect was rejectable per product specification.A physical sample is required for a thorough evaluation to determine the most likely root cause.A corrective action will be performed based on the identified root cause.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.H3 other text : see h.10.

Event Description

It was reported that an unspecified number of syringe oral 3ml amber experienced a mix of product types in a pack which was noted prior to use.The following information was provided by the initial reporter: we have had a delivery of amber syringes, polypropylene, amber barrel and white tip cap where there are mixed lot numbers within the boxes.Our goods in have opened 26 boxes and out of these, four were found to have lot numbers mixed up within each box.The lot number/batch number on the documentation and outer box label is 9024705,the boxes in question had some bags with lot numbers of 9024703 inside.One box had 2 bags of incorrect lot number inside.Two boxes had 4 bags of incorrect lot number inside.One box had all 5 bags of incorrect lot number inside.All bags have been returned to their original boxes and the batch has been quarantined.

• Brand Name: SYRINGE ORAL 3ML AMBER
• Type of Device: LIQUID MEDICATION DISPENSER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9257220
• MDR Text Key: 195527427
• Report Number: 1213809-2019-01084
• 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,foreign,other
• Type of Report: Initial,Followup
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305210
• Device Lot Number: 9024705
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other