MAUDE Adverse Event Report: BECTON DICKINSON BD SYRINGE 1ML LS 25GA 5/8IN CHIN GRA; INTRAVASCULAR CATHETER

Catalog Number 300841

Device Problem Unsealed Device Packaging (1444)

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

Event Date 08/14/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd syringe 1ml ls 25ga 5/8in chin gra package seal integrity was poor / questionable the following information was provided by the initial reporter: our pharmaceutical production personnel reported that in the process of material picking, it was found that there were a few materials produced by your company (disposable sterile syringes with injection needles).The detailed process is "the release of materials in the release of the review found that there are 2 layers of tape on the packaging of the material (2 layers of tape is not our company's operation behavior), visual inspection of the following layer of tape has been opened; the 1356115 supplier batch in the library of 2 layers of tape of the material unpacking review quantity, found that there is a box less than 10, 90 in the box, 100 on the box label".Please investigate and provide a report, thanks.

Event Description

Our pharmaceutical production personnel reported that in the process of material picking, it was found that there were a few materials produced by your company (disposable sterile syringes with injection needles).The detailed process is "the release of materials in the release of the review found that there are 2 layers of tape on the packaging of the material (2 layers of tape is not our company's operation behavior), visual inspection of the following layer of tape has been opened; the 1356115 supplier batch in the library of 2 layers of tape of the material unpacking review quantity, found that there is a box less than 10, 90 in the box, 100 on the box label".Please investigate and provide a report, thanks.

Manufacturer Narrative

During manufacturing process, there is an auto ¿ check weigher performed per shift to maintain the correct count in packaging.The check weigher at the secondary packaging machine had been challenged and able to reject out parts with missing syringe as per syringe secondary packaging equipment checklist.Current control there is a 3 hourly outgoing inspection and 2 hourly in-process inspection in place to check for short count.The team have carried out simulation and confirmed that the auto-check weigher machine able to reject missing syringe for 10pcs.The nonconformance could have been escapees returned to auto-check weigher machine after rejected from line.The production technician could have unknowing returned the rejected box before topping up the missing syringe.Action has been taken re-train technician on re-process and re-weigh the carton.H3 other text : see h10 manufacture narrative.

• Brand Name: BD SYRINGE 1ML LS 25GA 5/8IN CHIN GRA
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18565918
• MDR Text Key: 333511477
• Report Number: 2243072-2024-00056
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

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 Catalogue Number: 300841
• Device Lot Number: 1356115
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/01/2024
• Initial Date FDA Received: 01/23/2024
• Supplement Dates Manufacturer Received: 03/07/2024
• Supplement Dates FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1