MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. SYRINGE 10ML SALINE XS

Catalog Number 306572

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 09/29/2020

Event Type  Injury  

Manufacturer Narrative

Date of birth: unknown. The patient¿s age was used to determine a placeholder date for this field. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4).

Event Description

It was reported that syringe 10ml saline xs was damaged. The following information was provided by the initial reporter: male patient aged (b)(6) and weighing (b)(6). The mother who was trained to unplug the parenteral nutrition of his child, gets dressed, prepares her equipment, opens the set of disconnection of ap (occlusive no shock), then at the moment of wanting to rinse the tubing, the team notices that the syringe pre-filled 10 ml is cracked, and dry. Consequences: delayed care.

Manufacturer Narrative

The following fields were updated due to additional information: d. 10. Device available for eval?: yes d. 10. Returned to manufacturer on: 11/16/2020 h. 6. Investigation: a device history record review was performed for provided lot number 9129750 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident. To aid in the investigation of this issue, the physical sample was returned for evaluation by our quality engineer team. Through examination of the sample, the barrel was observed cracked and the syringe was empty of saline. There are several points throughout the production process where the product is inspected and rejected if signs of defect are identified. The faulty sample was placed through the production line and was identified and rejected at both the fill station and the packaging loading stations. To further test the inspection systems, a second syringe was moved through the production process and deliberately jammed in the production line to cause damage. This test syringe was also rejected by the inspection systems. Based on the investigation results, we believe it is unlikely that this damage occurred within the manufacturing process. An exact cause for this damage cannot be determined at this time. See h. 10.

Event Description

It was reported that syringe 10ml saline xs was damaged. The following information was provided by the initial reporter: male patient aged 13 months and weighing 10kg. The mother who was trained to unplug the parenteral nutrition of his child, gets dressed, prepares her equipment, opens the set of disconnection of ap (occlusive no shock), then at the moment of wanting to rinse the tubing, the team notices that the syringe pre-filled 10 ml is cracked, and dry. Consequences: delayed care.

• Brand Name: SYRINGE 10ML SALINE XS
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 10856988
• Report Number: 9616657-2020-00167
• 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: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 306572
• Device Lot Number: 9129750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Age: 13 MO
• Patient Weight: 10
• Patient Outcome(s): Other