MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA

Catalog Number 301942

Device Problem Packaging Problem (3007)

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

Event Date 05/08/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that syringe s2 5ml 22ga 1-1/4in bd china package was damaged.The following information was provided by the initial reporter: on the morning of (b)(6) 2021, the responsible nurse collected blood from the vein of the child and kept the blood sample.When checking the materials, it was found that the packaging of the 5ml syringe was damaged and could not be used.The new syringe was immediately replaced and the operation was completed without causing harm to the child.

Event Description

It was reported that syringe s2 5ml 22ga 1-1/4in bd china package was damaged.The following information was provided by the initial reporter: on the morning of (b)(6) 2021, the responsible nurse collected blood from the vein of the child and kept the blood sample.When checking the materials, it was found that the packaging of the 5ml syringe was damaged and could not be used.The new syringe was immediately replaced and the operation was completed without causing harm to the child.

Manufacturer Narrative

H.6.Investigation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.H3 other text : see h.10.

Manufacturer Narrative

H.6.Investigation: a device history record review was completed for provided material number 301942 and lot number 2007128.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, three picture samples were returned for evaluation by our quality engineer team.Through examination of the pictures, two needle components were observed within the blister packaging when only one needle is supposed to be within the package.The entire packaging process, including the needle feeding system, is completed automatically.The packaging process includes several detection systems in order to identify any missing or extraneous needles.If an issue is detected, the machine will stop automatically and the operator will resolve the issue.This detection system is challenged every eight hours of production.It has been concluded that the pictured issue most likely resulted from human error.The detection system most likely detected the extra needle in the package; however, it was not properly resolved by the machine operator.

Event Description

It was reported that syringe s2 5ml 22ga 1-1/4in bd china package was damaged.The following information was provided by the initial reporter: on the morning of (b)(6) 2021, the responsible nurse collected blood from the vein of the child and kept the blood sample.When checking the materials, it was found that the packaging of the 5ml syringe was damaged and could not be used.The new syringe was immediately replaced and the operation was completed without causing harm to the child.

• Brand Name: SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12040430
• MDR Text Key: 257531234
• Report Number: 3002682307-2021-00269
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 03/03/2022

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: 301942
• Device Lot Number: 2007128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2021
• Initial Date FDA Received: 06/22/2021
• Supplement Dates Manufacturer Received: 07/07/2021; 03/03/2022
• Supplement Dates FDA Received: 07/29/2021; 03/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2020
• 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