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

Catalog Number 300865

Device Problem Crack (1135)

Patient Problem Loss of consciousness (2418)

Event Date 04/24/2023

Event Type  Injury  

Event Description

It was reported while using bd plastipak¿ syringes the product was damaged and air entered the line.The following information was provided by the initial reporter, translated from french to english: potential lot numbers: 2303013 or 2303053 or 2206024 or 2202033.Verbatim: the patient was found unconscious at 8 o'clock.Air is found in the tubing.Then we find that the syringe of the midazolam eps is full of air.The syringe is cracked.In addition to the air leak, the crack accelerated the passage of the drug in iv (approximately 30mg of midazolam in 24 hours).Patient found unconscious.After stopping the pes and treatment with naloxone and flumazenil the patient responded to the calls.Then transfer to palliative care, recovery and no long term consequences.

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 16-aug-2023.H6: investigation summary: one syringe sample received by our quality team for investigation.Through visual evaluation, the barrel is cracked, therefore the incident is confirmed.A device history review was performed for the possible lot numbers 2303013, 2303053, 2206024 and 220203, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.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 teams investigation, root cause of the incident is related with a hit during transport or manufacturing.Areas where pieces are transported in manufacturing area are protected to avoid damage on the product.

Event Description

It was reported while using bd plastipak¿ syringes the product was damaged and air entered the line.The following information was provided by the initial reporter, translated from french to english: potential lot numbers: 2303013 or 2303053 or 2206024 or 2202033.Verbatim: the patient was found unconscious at 8 o'clock.Air is found in the tubing.Then we find that the syringe of the midazolam eps is full of air.The syringe is cracked.In addition to the air leak, the crack accelerated the passage of the drug in iv (approximately 30mg of midazolam in 24 hours) patient found unconscious.After stopping the pes and treatment with naloxone and flumazenil the patient responded to the calls.Then transfer to palliative care, recovery and no long term consequences.

• Brand Name: BD PLASTIPAK¿ SYRINGES
• 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: 17167243
• MDR Text Key: 317635890
• Report Number: 3003152976-2023-00242
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903008650
• UDI-Public: (01)00382903008650
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300865
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2023
• Initial Date FDA Received: 06/20/2023
• Supplement Dates Manufacturer Received: 08/16/2023
• Supplement Dates FDA Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2023
• 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
• Patient Outcome(s): Required Intervention