MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 10ML LL W/BLUNT PLASTIC CANN; PISTON SYRINGE

Model Number	303348
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that an unspecified number of syringe 10ml ll w/blunt plastic can had damaged packaging before use.The following was reported by the initial reporter: "the customer reported about several damaged packages.The customer has experienced the same issue before and is strongly complaining that the issue has not been resolved.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 3/1/2021.H.6.Investigation: eight photos and a box containing thirty-eight packaged 10ml syringes with blunt plastic cannula confirmed to be from batch 0010862 (p/n 303348) were received and evaluated.Thirty-six physical packages were fully sealed and two packages were received torn open.The defective packages matched the samples in the photos.One defective package had its top web torn open and the syringe¿s blunt plastic cannula was found to be bent close to the luer collar.One defective package also had a torn top web, while the product inside was not damaged.The grid from the seal was confirmed to be fully present on both¿top and bottom¿webs of both packages, indicating there were no seal issues.Machine logs were reviewed, and packaging process evaluated.Investigation showed that it is possible a package misalignment inside the shelf carton prior to sealing could result in the misaligned packages near the top of the box to get crushed in the tape sealing station.There was a recorded instance of jams in the slitter station, which could have contributed to package misalignment.It is also possible offload robot jaws could have become out of alignment when placing packages inside a shelf carton.Based on the production records reviewed and investigation performed, the scope of the defect is likely limited to a few/several pieces in the batch.There is no indication this defect occurred at a high rate during the manufacture of batch 0010862 (303348).Potential root cause for the open seal defect is associated with the packaging process.Package misalignment likely contributed to a situation where one or more vertical syringes proceeded through the tamper and taping station.During the taping process these vertical syringes could have been forcefully tampered then sealed in the box.This potentially damaged the syringes further to the point of being unusable and compromised package integrity.
Event or Problem Description
It was reported that an unspecified number of syringe 10ml ll w/blunt plastic cann had damaged packaging before use.The following was reported by the initial reporter: "the customer reported about several damaged packages.The customer has experienced the same issue before and is strongly complaining that the issue has not been resolved.".

• Brand Name: SYRINGE 10ML LL W/BLUNT PLASTIC CANN
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11478696
• Report Number: 1213809-2021-00127
• Device Sequence Number: 19811601
• Product Code: FMF
• UDI-Device Identifier: 30382903033486
• UDI-Public: 30382903033486
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K974363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: 303348
• Device Catalogue Number: 303348
• Device Lot Number: 0010862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 03/14/2021
• Supplement Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1