MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ - 3-PIECE SYRINGE; PISTON SYRINGE

Catalog Number 305959

Device Problem Unsealed Device Packaging (1444)

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

Event Date 06/08/2023

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 prior to use with bd plastipak¿ - 3-piece syringe the packaging was damaged and syringe sticking out, thus affecting sterility.The following information was provided by the initial reporter: it goes without saying that these syringes fall far below the sterile standards i have previously associated with your products.Whilst the percentage of damage syringes within the brand new box of 100 was comparatively low i did not have the confidence in the standards of the rest of the box, and disregarded.I have however retained those that were the worst.It would appear that this is some kind of a sealing fault, with one packet having one and half syringes, alongside others being completely unsealed, or having a larger than average packet.

Event Description

It was reported that prior to use with bd plastipak¿ - 3-piece syringe the packaging was damaged and syringe sticking out, thus affecting sterilitly.The following information was provided by the initial reporter: it goes without saying that these syringes fall far below the sterile standards i have previously associated with your products.Whilst the percentage of damage syringes within the brand new box of 100 was comparatively low i did not have the confidence in the standards of the rest of the box, and disregarded.I have however retained those that were the worst.It would appear that this is some kind of a sealing fault, with one packet having one and half syringes, alongside others being completely unsealed, or having a larger than average packet.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for evalution?yes.D10: returned to manufacturer on: 04-jul-2023 h6: investigation summary both photos and physical samples were provided to our quality team for investigation.Through visual inspection, one syringe is observed to be broken into two parts and packaged with another device which is undamaged.It is also noted that one package was empty, indicating the broken device was misplaced during packaging and placed with the other device as seen with the sample and photos provided.A device history record review did not reveal any documented quality issues during the production of lot number 2207050 that could have contributed to this incident.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Based on the sample evaluation and damaged observed, it was determined this incident occurred as a result of the syringe being improperly positioned during the packaging process, the transversal cutters which separate the package hitting the syringe and causing it to be placed within the package with an existing device.

• Brand Name: BD PLASTIPAK¿ - 3-PIECE SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17226478
• MDR Text Key: 318197127
• Report Number: 3003152976-2023-00265
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305959
• Device Lot Number: 2207050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1