MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 1 ML ALLERGIST TRAY WITH 27 G X 1/2 IN. BD SAFETYGLIDE¿; PISTON SYRINGE

Catalog Number 305950

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/28/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: investigation summary: customer returned (1) 1 ml, 13 mm, 27g bd safetyglide allergy syringe with the tray cover from lot # 7116565.Customer states that the safety glide broke off and went flying in the air needle and all.The syringe was returned without the hub-needle/shield/safety mechanism.The barrel was examined and exhibited a slightly damaged barrel tip.Sample will be forwarded to manufacturing (b)(4) on 20oct2017 for further investigation.Upon completion of the secondary investigation, a second supplemental report will be filed.Based on the samples / photo(s) received the investigation concluded: - confirmed: bd was able to duplicate or confirm the customer¿s indicated failure complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Based on the above, no capa is required at this time.

Event Description

It was reported that the 1 ml allergist tray with 27 g x 1/2 in.Bd safetyglide¿ was in use with a nurse and went to flip the safety glide over the top of the needle when it completely broke off and went flying in the air.Needle and all.Lot # 716565.Found after use.No serious injury or medical intervention noted.

• Brand Name: 1 ML ALLERGIST TRAY WITH 27 G X 1/2 IN. BD SAFETYGLIDE¿
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6980009
• MDR Text Key: 91081737
• Report Number: 1920898-2017-00272
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903059508
• UDI-Public: 00382903059508
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K941657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 305950
• Device Lot Number: 7116565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/26/2017
• 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): Other