MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 1ML DN 25GA 5/8 SP120

Catalog Number 303175

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2021

Event Type  malfunction  

Manufacturer Narrative

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 syringe 1ml dn 25ga 5/8 sp120 experienced damaged or open unit packaging/seals where sterility was compromised.The following information was provided by the initial reporter: inside the box, two 1 ml syringes with slightly torn packaging were found.

Event Description

It was reported that 2 syringe 1ml dn 25ga 5/8 sp120 experienced damaged or open unit packaging/seals where sterility was compromised.The following information was provided by the initial reporter: inside the box, two 1 ml syringes with slightly torn packaging were found.

Manufacturer Narrative

H.6.Investigation: it has been received two pictures of two syringes 1ml lot 1811700 to perform investigation.Upon visual inspection of the pictures received, it can be observed the paper of both blisters are broken.Dhr of lot 1811700 has been reviewed finding an annotation that could be related to the alleged defect.During packaging process incidence was detected in packaging machine of this manufacturing line related to a bad elevation of the die when blisters are formed.Once detected mechanical team repaired the failure.This failure could cause blisters resulted damaged.H3 other text : see h.10.

Manufacturer Narrative

H.6.Investigation: it has been received two pictures of two syringes 1ml lot 1811700 to perform investigation.Upon visual inspection of the pictures received, it can be observed the paper of both blisters are broken.Dhr of lot 1811700 has been reviewed finding an annotation that could be related to the alleged defect.During packaging process incidence was detected in packaging machine of this manufacturing line related to a bad elevation of the die when blisters are formed.Once detected mechanical team repaired the failure.This failure could cause blisters resulted damaged.

• Brand Name: SYRINGE 1ML DN 25GA 5/8 SP120
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 11668606
• MDR Text Key: 253805477
• Report Number: 3003152976-2021-00199
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

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
• Device Operator: Other
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 303175
• Device Lot Number: 1811700
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/16/2021
• Initial Date FDA Received: 04/14/2021
• Supplement Dates Manufacturer Received: 05/06/2021
• Supplement Dates FDA Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1