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

Catalog Number 305217

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 08/14/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: n/a.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the bd¿ oral dispensing syringe box had no label on it.This was noticed before use.The following information was provided by the initial reporter: "on 08/14/20, we received an overage of 1cs bd oral syringe w/tip cap clear 500 x 1 ml ndc (b)(4) on po# (b)(4).This case has no info on the box (no product description) but in the box there are bd oral syringe w/tip cap clear.".

Event Description

It was reported that the bd¿ oral dispensing syringe box had no label on it.This was noticed before use.The following information was provided by the initial reporter: "on (b)(6) 2020, we received an overage of 1cs bd oral syringe w/tip cap clear 500x1ml ndc 8290305217 on po#: (b)(6).This case has no info on the box ( no product description ) but in the box there are bd oral syringe w/tip cap clear.".

Manufacturer Narrative

H.6.Investigation: one photo of a 1ml box was received and evaluated.It appeared the box was opened, and no label was present.The missing label defect was rejectable per product specification.Potential root cause for the missing label defect is associated with the packaging process.Dhr was performed.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Potential root cause for the missing label defect is associated with the packaging process.1) if the boxes are loaded onto the conveyor too close together the labeler will skip the second box.2) a gap in procedure exists at the packaging process to verify label presence on boxes and load boxes one at a time.H3 other text : see h.10.

• Brand Name: BD ORAL DISPENSING SYRINGE
• Type of Device: LIQUID MEDICATION DISPENSER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10512365
• MDR Text Key: 207359720
• Report Number: 1213809-2020-00612
• 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: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305217
• Device Lot Number: 0174881
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other